0607 anesthetic and antiemetic infusion pumps · 2020. 9. 3. · administration (fda) approval for...

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Anesthetic and Antiemetic Infusion Pumps

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History Last

Review

03/27/2019

Effective: 04/23/200

Next Review:

06/27/2019

Review History

Definitions

Additional Information

Number: 0607

Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

I. Aetna considers infusion pumps for intralesional administration of narcotic

analgesics and anesthetics experimental and investigational because the

effectiveness of these pumps has not been demonstrated in well-designed

clinical studies published in the peer-reviewed medical literature.

II. Aetna considers infusion pumps for intraarticular administration of narcotic

analgesics and anesthetics experimental and investigational because they

have not been proven to improve post-operative pain control.

III. Aetna considers infusion pumps for local administration of narcotic

analgesics and anesthetics following bariatric surgery, cardiothoracic

surgery, free flap breast reconstruction, laparoscopic cholecystectomy,

open inguinal hernia repair experimental and investigational because of

insufficient evidence of its effectiveness.

http://www.aetna.com/cpb/medical/data/600_699/0607.html 09/24/2019

http://www.aetna.com/cpb/medical/data/600_699/0607.html

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IV. Aetna considers continuous subcutaneous antiemetic pumps experimental

and investigational because the effectiveness of these pumps has not been

demonstrated in well-designed clinical studies published in the peer-

reviewed medical literature.

Note: This policy does not apply to continuous peripheral nerve blocks (e.g.,

brachial plexus blocks, femoral nerve blocks, inter-costal blocks).

See also

CPB 0010 - Continuous Passive Motion (CPM) Machines (../1_99/0010.html),

and CPB 0161 - Infusion Pumps (../100_199/0161.html).

Background

Anesthetic Infusion Pump

Pain relief after surgery is often provided by patient-controlled systemic analgesia,

which uses an intravenous infusion pump and a patient-activated switch to

administer narcotic analgesics.

In order to avoid the complications associated with systemically administered

narcotic analgesia, infusion pumps have been developed to administer narcotic

analgesics and anesthetics directly into the lesion. The On-Q Pain Management

System, the Pain Buster Pain Management System, the Don Joy Pain Pump, and

the Stryker Pain Pumps are brand names of devices designed to provide pain relief

at the operative site for patients recovering at home from day surgery. These

devices have been used most frequently for patients who have undergone

orthopedic or "sports medicine" surgery to repair knee and shoulder problems. It

should be noted that these devices have not received Food and Drug

Administration (FDA) approval for intra-articular delivery of local analgesics and

anesthetics.

Attached to the catheter is a small plastic pump that automatically directs a local

anesthesia to the source of the pain. The pumps have been used to dull the pain

and eliminate the need for systemic narcotic and non-narcotic analgesics.

Narcotics have also been infused directly into inflamed tissue. The device is



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secured to the body until the narcotic medication or anesthetic is depleted, and the

patient can remove it him/herself. The manufacturers of these devices claim that

patients treated in this way are able to move around sooner following surgery and

participate in rehabilitation with greater ease, and require fewer drugs to aid in

recovery.

Studies in the medical literature, however, have not shown better patient outcomes

(in terms of enhanced pain relief, reductions in disability, improvements in function

or faster recovery) when these devices are used in place of or in addition to

standard (systemic) administration of narcotics.

Well-designed randomized controlled clinical studies evaluating both subjective

endpoints of reduction in pain and objectively measured functional endpoints

(reductions in disability and improvement in function) are especially important in

evaluating pain interventions because of the susceptibility of pain to placebo

effects. The study by Alford et al (2003) found reductions in pain and narcotic use

in subjects both subjects receiving intra-articular anesthetic and subjects receiving

intra-articular saline compared to a comparison group receiving no catheter,

suggesting an important placebo effect from intra-articular infusion pumps. These

findings were consistent with a study by Rosseland et al (2004), which found

significant effects of intra-articular infusion of saline.

A study by Alford et al (2003) is significant in that it reported on functional outcomes

(reductions in disability, improvements in function) in addition to subjective pain

scores and narcotic consumption. The investigators found no significant

differences in functional outcomes (range of motion, straight leg raises) between

the group receiving intra-articular anesthetic and the group receiving intra-articular

saline. Other randomized controlled clinical studies of intra-articular and intra-

lesional anesthetic pumps are of weaker design than this study if they report only

on pain scores and supplemental analgesic use, and not on functional outcomes.

Available studies do not consistently demonstrate clinically significant reductions in

narcotic consumption in subjects receiving intra-articular or intra-lesional

anesthetic. In some studies, there was no significant reduction in narcotic usage in

subjects assigned to intra-articular or intra-lesional anesthetic infusion compared to

subjects assigned to intra-articular or intra-lesional saline infusions.



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In available studies, the reported reductions in pain scores in groups receiving intra-

articular or intra-lesional anesthetics were generally modest and inconsistent, with

some studies reporting significant reductions in some types of pain with intra-

articular or intra-lesional anesthetic but not others.

A number of studies have failed to find any significant effect of intra-articular or intra-

lesional infusion of anesthetics (Boss et al, 2004; Drosos et al, 2002; Aasbo et al,

1996; Henderson et al, 1990; Joshi et al, 1993; Klasen et al, 1999; Schwarz et al,

1999; Rautoma et al, 2000; and DeWeese et al, 2001).

There are a paucity of studies that have directly compared the effectiveness and

safety of intra-articular or intra-lesional infusions with established methods of post-

operative analgesia. Several such studies have been published, showing intra-

articular or intra-lesional infusion to offer inferior post-operative pain relief (Dauri et

al, 2003; Iskandar et al, 2003).

Available studies are small and not sufficiently powered to evaluate uncommon but

clinically significant adverse effects of intralesional catheters. The maintenance of

a catheter in the wound may have an effect on infection and wound healing. In

addition, anesthetics used in continuous wound perfusion have vasoconstrictive

properties that may adversely affect wound healing by decreasing blood flow to

injured tissues. Systemic absorption of large doses of anesthetic may be toxic.

In summary, available studies suggest that pain relief from intra-lesional and intra-

articular anesthetics, if any, is modest and it remains unclear whether any

analgesia produced by intra-articular and intra-lesional anesthetics is clinically

useful.

Alford et al (2003) reported on the effectiveness of post-operative intra-lesional

anesthetic infusion after anterior cruciate ligament reconstruction. This study is

significant in that it is a blinded, randomized, controlled clinical study that examined

not only subjective pain endpoints and narcotic consumption but also objective

endpoints of physical function. In this study, 49 patients were randomly assigned

to 1 of 3 groups: (i) no catheter, (ii) an infusion catheter filled with saline, and (iii)

an infusion catheter filled with anesthetic. The only statistically shown benefit of

intra-lesional anesthetic infusion over saline infusion was in maximum pain ratings.

Median pain ratings were significantly lower in both catheter groups compared with

the group receiving no catheter; however, there were no significant differences in




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median pain ratings between the catheter groups. Only the saline catheter group

had significantly less narcotic consumption than the no catheter group. Narcotic

consumption of the anesthetic catheter group was intermediate between the saline

catheter group and the no catheter group, and not statistically significantly different

than the no catheter group. Physical therapy data showed no significant

differences in range of motion on post-operative day 4 among groups. Significantly

more patients were able to perform straight leg raises during the first physical

therapy session in both the saline catheter group (70 %) and the anesthetic

catheter group (72 %) than the control group (50 %). This study suggested a

strong placebo effect from the use of a saline catheter. There were no consistent

differences in outcomes between the saline catheter and anesthetic catheter

groups.

Gupta et al (2002) reported on a prospective, double-blind, randomized controlled

clinical study of 40 subjects undergoing laparoscopic cholecystectomy. This study

was of stronger design than many other randomized controlled clinical studies of

intra-lesional anesthetic pumps in that it includes as outcome measures both

subjective assessments of pain and objective assessments of supplemental

narcotic pain medication consumption, reductions in disability and improvements in

function. This study found a modest benefit to intralesional anesthetic pumps that

was limited to only the first few hours after surgery. Statistically significant

differences in pain intensity (visual analog scale [VAS] scores) between patients

receiving intra-lesional anesthesia versus intra-lesional saline infusion were limited

to deep pain and pain during coughing during the early post-operative period

(within 4 hours following surgery), with no differences in pain at the shoulder or

incisional sites. There were no significant differences in VAS scores between

groups more than 4 hours after surgery. However, these investigators noted that,

in general, the pain intensity was mild, even in the placebo group. There were no

significant differences between groups in the amount of supplemental narcotic

analgesic medication used, in the number of patients requiring no supplemental

narcotic analgesic medication, or in the number of patients requiring higher doses

of narcotic medication. There were also no differences between groups in objective

measures of post-operative recovery: time to transfer from phase 1 to phase 2

recovery, time to sit up in bed, time to stand and walk without support, time to drink

and eat, time to void, and time to discharge home. The most common post-

operative complication was nausea, which was significantly more common in

subjects receiving intra-lesional anesthesia. No differences were seen between the


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groups during the first week. The median times to start eating regularly, walking

normally, defecating, driving the car, and return to normal activities of daily living

were also similar between groups.

A study by Schurr et al (2004) of intra-lesional anesthetic infusion in 80 patients

undergoing inguinal herniorrhaphy is also a prospective double-blind, randomized,

controlled clinical trial, that assessed both pain and objective functional outcomes

(activity, return of bowel function). These investigators reported a “mild reduction”

in worst pain in patients receiving intra-lesional anesthesia (mean 6.7) than patients

receiving saline (mean 5.0). There was no reduction in the total amount of time

spent in moderate pain between groups. On day 1, least pain ratings were also

lower, and patients ambulated more frequently than those who received placebo.

The investigators reported no differences between groups from post-operative day

2 to 5. In addition, the investigators reported no differences between groups in

hydrocodone consumption. The investigators concluded that intra-lesional

anesthetic infusion provided modest improvements in pain scores and functional

outcomes when compared with placebo. The investigators noted, however, that

these effects were limited to the first post-operative day only. The investigators

considered that the same effect may be achieved by administering a pre-operative

dose of an extended-release oral opioid or a non-steroidal anti-inflammatory drug

(NSAID) without anti-platelet effects to control background pain in the immediate

post-operative period and for the first 24 hours. The investigators reported 5 % of

the infusion pumps failed immediately, and 19.4 % of subjects who completed the

study reported leakage of the infusion fluid from around the catheter infusion site.

The investigators noted a 4 % infection rate among study subjects, which is 10

times the historical rate of infections associated with this procedure for the

investigators’ institution. The investigators stated that this study was too small to

evaluate infection risk, and that a larger prospective study comparing intra-lesional

anesthetic infusion versus no infusion is needed to completely define this risk. The

investigators concluded that “[a]lthough continuous infusion of bupivacaine after

inguinal herniorrhaphy provides multi-modal post-operative pain therapy, the pain-

related outcomes are modestly improved at best and are limited to the first post-

operative day. The high incidence of leakage from the skin site and suggestion of

increased infection risk alter the risk-to-benefit ratio of this technique”. The

investigators concluded that the additional costs associated with intra-lesional

anesthesia may limit its widespread use in clinical practice.



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A study by Sanchez et al (2004) of 45 patients undergoing inguinal hernia repair is

also of weaker design than previously described studies. Although this is a

randomized, blinded study, only patients’ perception of pain and analgesic use

were assessed, and objective measures of post-operative recovery were not

assessed. Although the investigators reported significant differences in pain scores

in patients assigned to intra-lesional anesthesia versus placebo on post-operative

days 2 through 5, there were no significant differences between groups in the

amount of narcotic analgesics that were used.

A study by LeBlanc et al (2005) of 52 patients undergoing open inguinal

herniorrhaphy is also of weaker study design because outcomes were limited to

pain scores and analgesic use, and post-operative recovery was not assessed.

Pain VAS scores were not significantly different between groups. Narcotic use was

significantly higher in placebo subjects, but narcotic use decreased significantly in

both groups beyond the first post-operative day. There was no difference in

duration of hospital stay between groups.

Noting that "the effectiveness of continuous intra-bursal infusion of analgesics for

prolonged pain is yet unproven," Park et al (2002) undertook a prospective,

randomized, double-blind, controlled clinical study of intra-bursal infusion of

anesthesia versus saline in 60 patients following subacromial arthroscopy

procedures. All subjects received a post-operative intra-bursal bolus of

anesthetics. One group also received a continuous infusion of anesthetic into the

subacromial space, and the control group received a continuous infusion of saline

into the subacromial space. The anesthetic group reported significantly less rest

pain, but there was no difference in pain caused by movement. In the anesthetic

group, lesser amounts of supplemental analgesics were used in the first 2 days post-

operatively, and there was no significant difference in supplemental analgesics on the

3rd day post-operatively. This study is of weaker design than the previously described

study by Alford et al (2003) in that it only assessed post-operative pain and

medication use, and did not assess objective functional measures.

Noting that "at present, there is no clinical evidence of real effectiveness and safety

of continuous wound perfusion after spinal surgery," Bianconi et al (2004) reported

on a study of 37 patients undergoing posterior lumbar arthrodesis who were

randomized into 2 groups: (i) one group received a n intravenous analgesic

infusion following surgery, and ( ii) the other group received a n infusion of local

anesthetic directly into the surgical area. Pain scores, use of rescue medication,



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and duration of hospital stay were less in the group receiving a local anesthetic

infusion. However, the intravenous analgesic infusion was discontinued after 24

hours following surgery, while the continuous wound perfusion was maintained for

55 hours.

Dauri et al (2003) compared the effectiveness of epidural, continuous femoral

block, and intra-articular analgesia in 60 patients undergoing anterior cruciate

ligament reconstruction. Patients were randomly assigned to receive continuous

epidural ropivicaine, continuous ropivicaine femoral block, or continuous intra-

articular ropivicaine. The investigators reported that visual analog pain scores were

significantly higher in the group receiving intra-articular anesthetic 24 hours

following surgery, and that use of supplementary analgesics was significantly

higher in the group receiving intra-articular anesthetic throughout the post-operative

observation. The investigators also reported that intra-articular analgesia was

associated with a lower degree of patient satisfaction. The investigators concluded

that epidural or continuous femoral nerve block provide adequate pain relief in

patients undergoing anterior cruciate ligament reconstruction, whereas intra-

articular analgesia seems unable to cope satisfactorily with the analgesic

requirements of this surgical procedure.

Gupta et al (2004) reported on the results of a randomized controlled clinical trial

comparing continuous intra-peritoneal infusion of levobupivacaine versus normal

saline placebo in 40 women undergoing elective abdominal hysterectomy. The

investigators found a reduction in opioid consumption in the levobupivacaine group

lasting from 4 to 24 hours after surgery, which was associated with a reduced

incidence of nausea. Despite a reduction in analgesic requirement during this

period with levobupivacaine infusion, patients had moderate pain during coughing,

which the investigators concluded was “unsatisfactory.” In addition, no differences

were found between the groups in other endpoints, including vomiting, time to

eating, drinking, mobilizing, or home discharge.

Boss et al (2004) examined the effectiveness of continuous subacromial

bupivacaine infusion in 42 patients undergoing acromioplasty and rotator cuff

repair. Patients were randomly assigned to subacromial continuous infusions of

bupivacaine or saline (placebo). The investigators reported no significant

differences in supplemental opioid consumption by intravenous patient controlled

analgesia, in anti-emetic use, or in subjective pain perception by VAS between the



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groups. The investigators concluded that the continuous subacromial infiltration of

bupivacaine anesthetic is ineffective in providing pain relief after rotator cuff repair

and acromioplasty surgery.

Fredman et al (2001) reported on the analgesic efficacy of patient-controlled wound

instillation of the analgesic bupivacaine in 50 patients undergoing major abdominal

surgery. Subjects were randomly assigned to either bupivacaine or sterile water.

The investigators found no significant differences between groups in the amount of

rescue opioid requirements during the 24 hour study period. The investigators

reported that VAS for pain were similar between groups at rest, on coughing, and

after leg raise. The investigators concluded that bupivacaine wound instillation via

patient controlled analgesia pump does not decrease pain or post-operative opioid

requirements after abdominal surgery.

In a randomized study, Zieren et al (1999) compared the effect of repeated intra-

lesional boluses of local anesthetic to oral analgesic in 104 patients undergoing

tension-free inguinal hernia repair. Patients were randomly assigned to post-

operative repeated boluses of bupivacaine analgesic through a subcutaneous

catheter or oral analgesic dipyrone administered 6, 12, and 24 hours after

operation. The investigators reported no significant differences between groups in

absolute pain scores, course of pain, and the effects of analgesics. There were no

differences in duration of hospital stay between groups. The investigators

concluded that repeated intra-lesional boluses of local anesthetic did not result in

better pain control than oral analgesics after tension-free inguinal hernia repair.

Schurr et al (2004) evaluated post-operative continuous wound infusion of the local

anesthetic bupivacaine to saline placebo in patients undergoing inguinal

herniorrhaphy. The investigators reported that patients ho received bupivacaine

had lower ratings for worst pain than patients who received saline. On day 1, least

pain ratings were lower in patients receiving bupivacaine, and patients ambulated

more frequently than those who received placebo. However, these differences did

not persist beyond the first post-operative day, and there were no differences

between groups between post-operative days 2 through 5. The investigators also

reported no differences between groups in rescue narcotic consumption. The

investigators concluded that continuous infusion of local anesthetic after inguinal

herniorrhaphy provided “modest” improvements in pain scores and functional

outcomes when compared with placebo. However, the investigators noted that

these effects were limited to the first post-operative day only.



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Bianconi et al (2003) reported on the results of a randomized trial comparing

intravenous infusion of morphine plus ketorolac to continuous wound infusion of the

anesthetic ropivicaine in 37 patients undergoing hip or knee joint replacement

surgery. The investigators reported that the group receiving the continuous wound

instillation of had less post-operative pain at rest and on mobilization, less use of

rescue medication, and a shorter hospital stay, than the group receiving

intravenous analgesics. However, the intravenous medication was discontinued

after 24 hours, while the continuous wound instillation was continued for 55 hours.

The investigators noted that this was the only study of continuous wound instillation

of local anesthetic after hip or knee arthroplasty, and that further studies may be

necessary to confirm the efficacy of this new pain management strategy.

Axelsson et al (2003) reported on a study involving 30 patients undergoing

arthroscopic subacromial decompression who were randomized into 3 groups: (i)

group 1 received a pre-operative bolus of intra-bursal anesthesia p lus a

patient-controlled inf usion of anesthesia v ia a s imple elastomeric balloon

pump int o the subacromial space; (ii) group 2 received a p re-operative bolus of

intra-bursal saline plus a p atient-controlled inf usion of anesthesia into the

subacromial space via balloon pump; and ( iii) group 3 received a pre-operative

bolus of saline plus a p atient-controlled infusion via b alloon pump of saline

into the subacromial space. Post-operative pain at rest and on movement was

significantly lower in group 1 than in group 2 or 3 during the first 30 mins post-

operatively, suggesting that the difference among groups in pain relief was due to

the pre-operative bolus of anesthesia rather than the post-operative intra-bursal

anesthesia. Two patients in group 1 required supplemental morphine post-

operatively, compared to 6 persons in group 2 and 9 persons in group 3. After the

first hour the pain at rest decreased in all 3 groups, so that from the 4th post-

operative hour, the VAS scores were between 1 and 2 cm in all groups. No

significant differences were found between all 3 groups in the verbal rating score

(VRS) during the first 24 hours after the operation. The investigators also assessed

pain relief before and after a patient-controlled infusion. Pain at rest decreased in

all groups in all 3 groups, with no significant differences between groups. Pain on

movement decreased from an average of 5.9 pre-infusion to 4.7 post-infusion in

group 1, 6.1 to 4.8 in group 2, and 6.3 to 6.1 in group 3. Although the pain relief

was statistically significant after anesthetic infusion in groups 1 and 2, the average

VAS scores remained just below 5 in groups 1 and 2, indicating that the anesthetic

infusion provides inadequate pain relief. There were no significant differences

among the 3 groups in nausea, vomiting, or pruritus among the groups.



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Rosseland et al (2004) reported that pain after knee arthroscopy is modest and short-

lived and can successfully be treated with intra-articular saline as placebo in a

randomized controlled study (n = 60). In this study, 60 patients who developed

moderate-to-severe pain after knee arthroscopy were randomly assigned to

infusion of either 10 ml or 1 ml of intra-articular saline. The investigators reported

that pain intensity remained low and use of rescue medication and other pain

outcome measures were similar during the 36-hour outcome period. The

investigators found that patients experienced equally good pain relief after intra-

articular injection of saline. The investigators concluded that this finding of a major

placebo effect of intra-articular saline has implications for the interpretation of

previously published placebo-controlled intra-articular analgesia studies.

Barber and Herbert (2002) reported on a randomized controlled clinical study of 50

consecutive patients undergoing arthroscopic shoulder surgery who were randomly

assigned to either a saline or anesthetic solution via an infusion pump following

surgery. Although subjects assigned to anesthetic had lower pain scores than

subject assigned to saline, there was no statistically significant difference between

groups in use of post-operative oral medication. Functional outcome measures

were not assessed in this study.

Harvey et al (2004) reported on a randomized, controlled clinical study of 24

patients undergoing arthroscopic subacromial decompression, 19 of whom

completed the study. Subjects were randomly assigned to continuous subacromial

infusions of either anesthetic or saline. Subjects assigned to anesthetic had less

pain than subjects assigned to saline. However, there were no significant

differences between groups in the amount of supplemental hydrocodone

consumption. Functional outcome measures were not assessed in this study.

Savoie et al (2000) reported on 62 consecutive patients undergoing arthroscopic

subacromial decompression who were randomized to receive continuous intra-

lesional infusions of either anesthetic or saline post-operatively. Subjects assigned

to anesthetic infusion reported modest but statistically significant reductions in pain

scores post-operative days 1 through 5. Subjects assigned to anesthetic infusion

also had less use of supplemental narcotics. Functional outcomes were not

assessed.



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A study by Gottschalk et al (2003) examined the effectiveness of continuous intra-

lesional anesthetic infusion in 45 patients undergoing shoulder surgery. Subjects

were assigned to 3 groups: group 1 received a single dose wound infiltration of

saline plus continuous post-operative wound infiltration with saline; groups 2 and 3

received a single dose wound infiltration with anesthetic, plus continuous post-

operative wound infiltration with either lower dose or higher dose anesthetic.

Because of the design of this study, one can not discern the contributions of single

dose wound infiltration and post-operative continuous wound infiltration to

outcomes. Post-operative pain was less in the group receiving higher dose

anesthetic than lower dose anesthetic or saline during the 48 hour duration of the

study. Cumulative supplemental analgesic consumption was less in the subjects

receiving intra-lesional anesthetic. Functional outcomes were not assessed.

Klein et al (2003) compared the effectiveness of interscalene brachial plexus block

followed by continuous intra-articular infusion to interscalene brachial plexus block

followed by continuous interscalene infusion in 17 patients who were undergoing

outpatient rotator cuff repair. The investigators reported similarly high VAS scores

at rest and with movement and similarly high narcotic consumption between the 2

groups. The investigators noted that, overall, between 50 % and 70 % of all

patients reported suboptimal analgesia, and that neither group was consistently

able to achieve satisfactory analgesia (VAS less than 2) with supplemental oral

narcotics. The investigators concluded that “[t]he high VAS scores and need for

additional medical care suggest that intra-articular administration may not be

reasonable for this magnitude of surgery.”

Klein et al (2001) examined the effects of intra-articular analgesia with a continuous

infusion of local anesthetic in 40 patients undergoing shoulder arthroscopy.

Patients were randomly assigned to post-operative intra-articular infusion of

anesthetic or saline. Subjects assigned to anesthetic had lower post-operative pain

scores and less consumption of supplemental narcotics. Functional measures

were not assessed.

A study by Lau et al (2001) of 44 persons undergoing inguinal hernia repair is of

weaker design because it is non-blinded with no sham infusion pump treatment

given to the control group. The investigators reported significant differences in pain

scores in favor of the pump group lasting through the first day following surgery.

They also reported none of the 20 subjects assigned to intra-lesional infusion

pumps required analgesics, compared to 6 of 24 subjects in the control group.



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Because of the unblinded nature of this study, it is uncertain whether these

differences may be attributable to placebo effects. There were no differences

between groups in post-operative recovery, including time to resume ambulation,

time to resume voiding, and return to normal activities. The investigators reported

that the main drawbacks to the use of an intra-lesional pump were its high cost and

the frequent seepage of blood-stained anesthetic fluid into the wound dressing,

which occurred in a quarter of subjects assigned to intra-lesional anesthetic pumps.

A study by Cheong et al (2001) of 70 persons undergoing laparotomy for major

colorectal surgery is also non-blinded. Patients were randomly assigned to patient-

controlled analgesia (PCA) or to intra-lesional anesthesia. The investigators

reported that there was no statistically significant difference in post-operative pain

scores at rest and with movement between the 2 groups, except the first post-

operative day, where the median pain scores in the intra-lesional anesthesia group

were higher than those in the PCA group. The investigators reported that the

median amount of morphine used was significantly greater in the subjects assigned

to PCA than in subjects assigned to intra-lesional anesthesia. This difference may

be attributable to the non-blinded nature of this study and the fact that subjects

assigned to PCA could self-administer morphine on demand, whereas subjects

assigned to intra-lesional anesthesia had to request morphine administered via a

subcutaneous injection. The investigators noted that none of the patients in either

group was unduly sedated or confused owing to either form of analgesia during the

study. The investigators reported no significant differences in time to return of

bowel movement, time to post-operative mobilization, and time to discharge from

hospital. It should be noted that 4 patients in the intra-lesional anesthesia group

developed wound infection, compared to 1 patient in the PCA group.

A study by Morrison and Jacobs (2003) is also of weaker design in that it is non-

blinded, non-randomized retrospective consecutive case series of 49 mastectomy

patients treated over a 5-year period, with comparisons before and after

introduction of intra-lesional anesthetic infusion pumps. Factors other than the use

of an intra-lesional infusion pump (e.g., improvements in surgical techniques,

rehabilitation protocols, etc.) may have accounted for differences in use of post-

operative pain medication, length of hospital stay, and post-operative stay in post-

anesthesia care unit (PACU) before and after they began using intra-lesional

anesthetic pumps at the study institution.



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A study by Chew et al (2003) is of weaker design than many of the previously

described studies in that it is a non-randomized study that uses historical controls

rather than randomly assigned concurrent controls.

A study by Mallon et al (2000) is of weaker design in that it compares intra-articular

anesthetic infusion to no infusion, and hence the study is non-blinded and lacks a

placebo control group. Studies by Rawal et al (1997), Ganapathy et al (2000) and

Crawford et al (1997) are of weaker design in that they lack a control group. A

study by Yamaguchi et al (2002) is a report of a retrospective, uncontrolled case

series. A study by Vintar et al (2002) compared intra-lesional bupivacaine to intra-

lesional ropivacaine in 60 patients who underwent inguinal hernia repair, and hence

did not inform whether there are clinically significant benefits to the administration

of intra-lesional anesthesia.

Several studies after total knee arthroplasty (Klasen et al, 1999; Schwarz et al,

1999; Rautoma et al, 2000; DeWeese et al, 2001) and other surgical procedures

(Adams et al, 1991; Forgach and Ong, 1995) have concluded that application of

intra-articular or intra-lesional local anesthetics and/or morphine does not reduce

analgesic requirements, and there have been no studies to prove beneficial effects

on post-operative recovery and rehabilitation.

Nechleba et al (2005) examined the effectiveness of local, continuous infusion of

bupivacaine for pain control following total knee arthroplasty. A total of 11 men and

19 women with an average age of 65 years (range of 43 to 83 years) randomly

received either 0.25 % bupivacaine or normal saline by local infusion pump.

Standard wound drainage also was implemented. Pain was assessed with a VAS

along with patient-controlled analgesia demand, narcotic delivery, and NSAID

administration. Drug lost to drainage also was assessed. Mean pre-operative VAS

were similar between the saline and bupivacaine groups (6.5 +/- 1.4 and 6.1 +/- 2.0,

respectively; p = 0.535). By the end of the second post-operative day, scores

decreased to 3.4 +/- 3.2 for the saline group and 2.5 +/- 1.6 for the bupivacaine

group. Although post-operative reductions were statistically significant (p = 0.007),

the main treatment effect was not (p = 0.404). Mean narcotic demand and usage

were 87 +/- 114.1 requests with usage of 11.8 +/- 12.3 mg for the saline group and

96 +/- 104.8 requests with usage of 7.5 +/- 3.8 mg for the bupivacaine group (p =

0.505). Cumulative ketorolac administration was 47 +/- 52.2 mg for the saline

group and 83.6 +/- 64.9 mg for the bupivacaine group (p = 0.100). Hydrocodone-

acetaminophen usage also was similar between the saline and bupivacaine groups



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(88 +/- 43.9 mg and 64.6 +/- 35 mg, respectively) (p = 0.112). Drug lost to drainage

was estimated to be 27 %. These investigators concluded that their findings

suggested continuous local analgesic infusion after total knee arthroplasty does not

offer significant improvements in either pain relief or medication use. Drug loss

from drainage may exceed 25 % and may compromise analgesic effectiveness.

Other recently published studies also demonstrate the inconsistencies in results of

intralesional and intra-articular anesthetic pumps (Wu et al, 2005; Kushner et al,

2005; Morgan et al, 2006; Baig et al, 2006; Parker et al, 2007). In a prospective,

double-blind, placebo-controlled, randomized study, Wu et al (2005) examined if a

subfascial continuous infusion of local anesthetic in patients undergoing radical

retropubic prostatectomy would result in a reduction in post-operative opioid

requirements and an improvement in pain scores. A small catheter was placed

subfascially at the end of the operation and attached to an elastomeric pump, which

administered either 0.5 % bupivacaine or normal saline into the wound at a rate of 2

ml/hour until discharge on post-operative day 3. The outcomes assessed included

the dosage of hydromorphone used by a patient-controlled analgesic system, a

VAS for pain at rest and with activity, a VAS of nausea, and length of hospital stay.

A total of 100 patients were successfully randomized, with all patients completing

the protocol. No differences were found between the groups with regard to VAS

pain at rest, VAS pain with activity, intravenous or oral analgesic consumption, or

VAS nausea scores. The authors concluded that continuous subfascial infusion of

local anesthetic did not result in a post-operative reduction in opioid requirements

or an improvement in pain scores in patients undergoing radical retropubic

prostatectomy.

Continuous local anesthetic infusion has also been employed at the iliac crest bone

graft (ICBG) site following spinal arthrodesis. Singh et al (2005) examined the

effects of post-operative continuous local anesthetic agent infusion at the ICBG

harvest site in reducing pain, narcotic demand and usage, and improving early

post-operative function after spinal fusion. A total of 37 patients were enrolled in a

prospective, randomized, double-blind, parallel-designed study (28 had ICBG

harvested for lumbar arthrodesis and 9 for cervical arthrodesis). During spinal

arthrodesis surgery, patients were randomly assigned to receive 96 ml (2 ml/hour x

48 hours) of either normal saline (control group, n = 22) or 0.5 % Marcaine

(treatment group, n = 15) delivered via a continuous infusion catheter placed at the

ICBG harvest site. All patients received dilaudid patient-controlled analgesia after

surgery. Pain scores, narcotic use/frequency, activity level, and length of stay



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(LOS) were recorded. Physicians, patients, nursing staff, and statisticians were

blinded to the treatment. Mean patient age was 60 years and similar between

groups. Narcotic dosage, demand frequency, and mean VAS pain score were

significantly less in the treatment group at 24 and 48 hours (p < 0.05). The average

LOS was 4.1 days with no difference between the treatment group (4.3 days) and

the control (group 3.9 days). No complications were attributed to the infusion-

catheter system. The authors concluded that continuous infusion of 0.5 %

Marcaine at the ICBG harvest site reduced post-operative parenteral narcotic

usage by 50 % and decreased overall pain scores. No complications were

attributed to the infusion-catheter system. They noted that the use of continuous

local anesthetic infusion at the iliac crest may help in alleviating acute graft-related

pain, hastening patient recovery and improving short-term satisfaction. This is in

agreement with the findings of Cowan et al (2002) who stated that administration of

local anesthetic is a safe and effective technique for pain relief at the iliac crest

donor site in patients who have undergone cervical fusion (n = 14).

In contrast to the findings by Cowan et al (2002) and Singh et al (2005), Morgan

and colleagues (2006) reported that continuous infusion of bupivacaine at ICBG

sites during the post-operative period is not an effective pain control measure in

hospitalized patients receiving systemic narcotic medication. In a prospective, double-

blind, randomized clinical trial, Morgan et al (2006) examined if continuous infusion of

0.5 % bupivacaine into the iliac crest harvest site provides pain relief that is superior

to the relief provided by systemic narcotic pain medication alone in patients

undergoing reconstructive orthopedic trauma procedures. Patients (over 18 years

of age) were randomized to the treatment arm (bupivacaine infusion pump) or the

placebo arm. Post-operatively, all subjects received morphine sulfate with use of a

patient-controlled analgesia pump. Subjects recorded the pain at the donor and

recipient sites with use of a scale ranging from 0 to 10. The use of systemic narcotic

medication was recorded. Independent-samples t tests were used to assess

differences in perceived pain relief between the treatment and control groups at 0, 8,

16, 24, 32, 40, and 48 hours after surgery. Pain was also evaluated at 2 and 6 weeks

post-operatively. A total of 60 patients were enrolled. Across all data points, except

pain at the recipient site at 24 hours, no significant differences in the perception of

pain were found between the bupivacaine group and the placebo group. It is

interesting to note that on the average, patients in the treatment group reported more

pain than those in the control group. No significant difference was found between the

2 groups with regard to the amount of narcotic medication used. The authors

concluded that no difference in perceived pain was



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found between the groups. The results of this study indicated that continuous

infusion of bupivacaine at ICBG sites during the post-operative period is not an

effective pain-control measure in hospitalized patients receiving systemic narcotic

medication. This is in agreement with the observation of Puri et al (2000) who

stated that in view of the lack of improvement in pain relief and the risk of infection,

local administration of bupivacaine at the iliac bone harvest site following cervical

diskectomy/foot arthrodesis (n = 13) is not recommended for post-operative

analgesia.

Polglase et al (2007) reported on a lack of efficacy of a continuous wound infusion

of ropivacaine in conjunction with best practice post-operative analgesia after

midline laparotomy for abdominal colorectal surgery. The investigators performed a

randomized, participant and outcome assessor-blinded, placebo-controlled trial on

patients presenting for major abdominal colorectal surgery. Subjects were

allocated to receive ropivacaine 0.54 % or normal saline via a dual catheter

Painbuster Soaker continuous infusion device into their mid-line laparotomy wound

for 72 hours post-operatively. A total of 310 patients were included in this study.

The investigators found that the continuous wound infusion of ropivacaine after

abdominal colorectal surgery conveys minimal benefit compared with saline wound

infusion. The investigators found no statistically significant difference for: pain at

rest, morphine usage, length of stay, mobility, nausea, or return of bowel function.

There was a small, statistically significant difference in mean pain on movement on

day 1 for the ropivacaine group (adjusted mean difference -0.6 (range of -1.08 to

-0.13)). The investigators reported that, although this trend continued on days 2

and 3, the differences between groups were no longer statistically significant. The

investigators concluded that delivery of ropivacaine to midline laparotomy wounds

via a Painbuster Soaker device did not demonstrate any significant clinical

advantage over current best practice.

Liu et al (2006) conducted a systematic evidence review of intra-lesional and intra-

articular anesthetic pumps. The authors stated that they were motivated to conduct

a systematic review of continuous wound catheters delivering local anesthetic

because “there have been conflicting reports of the overall efficacy, and no single,

large randomized control trial (RCT) has definitively assessed the risk of this

modality.” Available randomized controlled clinical studies of continuous wound

catheters are small considering the size of the eligible population. A primary

problem with this systematic review is that it inappropriately combined studies

involving heterogenous patient populations, anesthesia indications, catheter



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placement, and methods of continuous infusion in its overall and subgroup

analyses. The authors noted that future large homogenous randomized controlled

trials would be valuable to verify the findings of the systematic review and provide

better quantitative data. In addition, the authors stated that they were not able to

answer basic questions, including cost-effectiveness, site of catheter placement, or

dosage, because of the variability among studies.

It remains unclear whether any analgesia produced by intra-articular and intra-

lesional anesthetics is clinically useful. Estimates of the impact of intra-lesional and

intra-articular anesthetic pumps on duration of hospitalization were based upon

very few studies. Few studies have examined the impact of intra-articular and intra-

lesional anesthetic pumps on functional outcomes (reductions in disability,

improvements in function, or faster recovery). In addition, few studies have directly

compared the effectiveness and safety of intra-articular or intra-lesional infusions

with established methods of post-operative analgesia (Tran et al, 2005). Finally,

available studies are small and not sufficiently powered to evaluate uncommon but

clinically significant adverse effects of intra-lesional and intra-articular catheters

(Hoeft et al, 2006).

In a retrospective study, Bray and colleagues (2007) evaluated the effectiveness of

a local anesthetic pain infusion pump in the management of post-operative pain in

abdominoplasty patients. A total of 38 abdominoplasty patients with local

anesthetic pain pumps and 35 abdominoplasty patients without pain pumps were

included in this study. Pain pumps were loaded with 0.25 % or 0.5 % bupivacaine

and infused at a constant rate of 4 ml/hour. All patients were admitted post-

operatively and started on a narcotic PCA. Post-operative PCA narcotic use and

pain scores were recorded every 2 hours by the nursing staff. For the first 24 hours

of post-operative hospital stay, pain medication, pain scores, and anti-emetic use

were determined from the patients' charts. Hospital stay was also reviewed. In the

pain pump group, there was a small but statistically non-significant reduction in pain

medication use (2.65 versus 3.04 pain units) (p = 0.34). Interestingly, pain scores

were higher in the pain pump group but not significantly (2.73 versus 2.31) (p =

0.17). There was no statistically significant difference in the use of anti-emetics

(0.8 versus 0.6) (p = 0.60). Hospital length of stay averaged 2.2 days in the pain

pump group and 2.5 days in the group without pain pumps (p = 0.09). The authors

concluded that the post-operative use of pain pumps in abdominoplasty patients



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does not significantly improve pain management. They stated that further

investigation into this application of the pain pump is necessary before

recommending their routine use in abdominoplasty patients.

Charous (2008) stated that management of post-operative pain can be critical to

the success of a patient's recovery following head and neck surgery. Various

medications and delivery methods have been tried to maximize patients' comfort

while minimizing many of the medications' potential side effects. Continuous

wound perfusion pain management systems are being used in various surgical

specialties. In a preliminary report, the author described the use of one such pain

management system (On-Q) in thyroid and parotid surgeries. Statistically

significant less levels of pain, use of opioids and nausea/vomiting were noted in

patients who used the On-Q system. There were no complications. The author

concluded that the use of the On-Q system in various head and neck procedures is

promising; further research, evaluation, and exploration of its possible uses are

encouraged.

In a prospective, randomized, double-blind study, Banerjee and associates (2008)

assessed the effectiveness of continuous low-dose bupivacaine infiltration by

infusion pump after arthroscopic rotator cuff repair. A total of 60 patients

undergoing arthroscopic rotator cuff repair received a bolus injection in the

subacromial space of 35 ml of 0.25 % bupivacaine with 1:200,000 epinephrine at

surgical closure and were randomized to 1 of 3 groups: (i) 0.25 % bupivacaine at 2

ml/hr (n = 20), (ii) 0.25 % bupivacaine at 5 ml/hr (n = 20), or (iii) saline at 5 ml/hr

(n = 20) via infusion pump into the subacromial space. Pain was evaluated using

the VAS and narcotic consumption was measured until 48 hours after surgery and

converted to dose equivalents (DE). Sixty patients used the infusion pump for a

mean of 43.9 hours (range of 15.50 to 50.75 hours). Mean total narcotic

consumption, expressed in DEs, was 2.24 for the 2-ml group, 3.52 for the 5-ml

group, and 2.32 for the placebo group. Mean pain score was 2.9 for the 2-ml

group, 3.6 for the 5-ml group, and 3.3 for the placebo group. There were no

differences in operating room time or infusion pump use time among groups. The 2-

ml group had a non-significant trend toward less pain and lower narcotic

consumption. The 5-ml group evidenced a non-significant trend toward more pain

and higher narcotic consumption. The findings of this study neither supported nor

refuted the use of infusion pumps. The authors hypothesized that the placebo

group would experience greater pain than the 5-ml group; however, a non-



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significant trend toward the contrary occurred. A trend toward less pain in the 2-ml

group was not significant.

In a prospective, randomized, double-blind, controlled trial, Kazmier et al (2008)

examined the effectiveness of the pain pump after cosmetic breast augmentation.

A total of 25 women were enrolled in the study; 5 were eliminated from analysis

because of data inadequacy or device problems. After bilateral augmentation, the

remaining 20 patients received a 4-day continuous infusion of bupivacaine in one

breast pocket and saline in the other. Laterality of bupivacaine infusion was

randomized and blinded to both the patient and the surgeon. Patients completed a

questionnaire on post-operative days 1, 2, 3, 4, and 7, rating their pain on a scale of

0 to 10, with 10 being worst. On post-operative day 1, the mean pain score was 4.7

on the bupivacaine side versus 5.4 on the saline side (p = 0.36). On post-operative

days 2, 3, 4, and 7, the mean scores were 4.3 versus 4.6 (p = 0.63), 3.3 versus 3.8

(p = 0.50), 3.4 versus 3.6 (p = 0.78), and 3.4 versus 3.1 (p = 0.63) for the

bupivacaine and saline sides, respectively. The authors concluded that the pain

pump appears to provide breast augmentation patients marginal improvement in

pain control, although this advantage did not reach statistical significance in this

study. The benefit, if real, also appears to wane over the first post-operative week.

Ciccone and co-workers (2008) assessed the effectiveness of interscalene regional

blocks and infusion pumps for post-operative pain control after arthroscopic

subacromial decompression with or without arthroscopic rotator cuff repair. A total

of 76 patients were included in the prospective study. Participants were

randomized into 4 treatment groups: (i) interscalene regional block, (ii) infusion

pump wit h 0.5 % bupivacaine, (iii) interscalene block combined wit h an infusion

pump c ontaining 0.5 % bupivacaine, and ( iv) interscalene block combined wit h

an infusion pump c ontaining 0.9 % saline solution. The interscalene regional

block was performed with a nerve stimulator. Infusion pump catheters were

positioned in the subacromial space. Visual analog scale data were collected pre-

operatively, at 1 and 2 hours post-operatively, and daily for an additional 6 days post-

operatively. An analysis of variance with a Student-Newman-Keuls post hoc test was

used to identify statistically significant (p < 0.05) differences in VAS scores between

the groups at each time point. Percentages of patients who took medication for pain

management in the recovery room were compared between the 4 groups by use of

chi(2) analysis. Significant differences were noted in VAS scores post-operatively.

Group (ii) (pump only) had significantly higher scores than all other groups for the

first 2 hours. Furthermore, group (iv) (block and pump filled



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with saline solution) had significantly lower VAS scores than group (i) (block only) at

1 hour. This difference was no longer significant by the second hour. The

percentage of patients who required oral narcotics or intravenous pain medication

was significantly larger for group (ii) than for the other groups. The authors

concluded that the interscalene regional block provided more pain relief than

infusion pumps immediately after arthroscopic shoulder surgery. Moreover,

infusion pumps did not significantly reduce pain levels after the blocks wore off.

An assessment by the Galacian Agency for Health Technology Assessment (AVALIA-

T) (Acevedo Prado and Atenzio Merino, 2008) found no clear evidence of improved

outcomes with continuous anesthetic infusion pumps versus other methods of

managing post-operative pain. The assessment identified 10 clinical trials that met

pre-specified inclusion criteria. The investigators found that, in general, the results of

these clinical trials did not consistently favor continuous anesthetic infusion pumps

over standard methods of postoperative pain management. The assessment found

that, in some of the clinical trials, there was a slight improvement in pain scores or

reductions requirements for narcotic analgesics, but other studies found no such

differences. One difficulty in interpreting studies that was noted in the assessment

is the lack of common methodology in clinical trials.

An assessment by IECS (Tapia-López, et al., 2016) stated that scarce and low-

quality evidence has shown no additional clinical benefit of elastomeric pumps over

other delivery devices in hospitals analgesics for pain management. Evidence for

the infusion of other drugs such as chemotherapeutic agents, antibiotics, antivirals

and chelating is insufficient. No studies comparing the use of elastomeric pumps in

the outpatient setting against other devices in hospitals were found.

In a randomized, controlled study, Reeves and Skinner (2009) examined the clinical

value of continuous intraarticular infusion of ropivacaine after unilateral total knee

arthroplasty (TKA). These investigators enrolled 66 patients scheduled for

unilateral TKA under general anesthesia and single-shot femoral and sciatic nerve

blocks. All patients had an intra-articular Painbuster device sited at the end of the

procedure. Patients were then randomized to control or 1 of 2 treatment arms: (i)

low-dose and (ii) high-dose ropivacaine. In the control group, the balloon was

filled with saline, in the low-dose group with 0.2 % ropivacaine and in the high-dose

group 0.375 % ropivacaine. The catheters were infused continuously for 48 hours

and then removed. Patients were followed-up daily for 3 days to determine pain



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scores, opioid consumption and subjective assessment of the analgesic efficacy of

the catheter. Data were analyzed for 30 controls and 31 in the treatment arms.

There were no significant differences between the control and treatment groups at

all time points after adjustment for age. Patients in the high-dose group had higher

pain scores and higher opioid consumption than the control groups from 24 to 48

hours. There were 2 cases of infection, both in the treatment groups. No positive

benefit of intra-articular infusion of local anesthetic after TKA could be identified.

On the contrary, there may be negative effects in terms of expense, pain and

possibly infection risks.

In a randomized, placebo-controlled, double-blind study, Chen et al (2010)

examined if continuous intra-articular infusion of bupivacaine via pain-control

infusion pumps (PCIP) enhances and sustains analgesia after total hip arthroplasty

(THA). A total of 92 patients undergoing THA were randomized to receive

continuous intra-articular infusion of either 0.5 % bupivacaine or 0.9 % normal

saline at a flow rate of 2 ml/hr via a PCIP for 48 hrs. The primary outcome measure

was pain intensity on VAS scores in the first 72 hrs. Other measures included time

to first rescue dose of narcotics, amount of narcotic use, presence of adverse

events, length of hospital stay, and hip function evaluated with the Western Ontario

and McMaster Universities Osteoarthritis (WOMAC) index. Despite a longer time to

first narcotic rescue (56 mins versus 21 mins, p < 0.0001) in patients receiving

bupivacaine, the 2 groups did not differ significantly in overall pain relief (p = 0.54).

A lower VAS score was found only at time 0-hr and 2-hr; no difference in VAS score

was noted at any other time point. Additionally, no difference was found in terms of

amount of narcotic use, incidence of adverse events, hospitalization days, and the

WOMAC score. The authors concluded that continuous intra-articular infusion of

0.5 % bupivacaine at 2 ml/hr via a PCIP does not provide sustained post-operative

pain relief in patients undergoing THA.

In a prospective, randomized study, Jarvela and Jarvela (2008) evaluated the long-

term effect of the use of a pain pump after arthroscopic subacromial

decompression. A total of 50 patients were included in this study (25 had a 24-hr

pain pump with 0.375 % ropivacaine infusion and a continuous rate of 5 ml/hr in the

subacromial space after arthroscopic subacromial decompression, and 25 did not).

Rehabilitation was similar in both groups. Evaluation methods were clinical

examination, radiographical evaluation, and isometric elevation strength

measurements, as well as the University of California, Los Angeles and Constant

shoulder scores. All the operations were done by 1 experienced orthopedic



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surgeon, and all the evaluations at follow-up were done by 1 independent, blinded

examiner. There were no differences between the study groups pre-operatively.

Of the patients, 47 (94 %) were available at a minimum follow-up of 2 years (range

of 24 to 32 months). Concerning the duration of sick leave (p = 0.053) and ability to

return to work (p = 0.321), the group differences were not statistically significant. At

follow-up, the shoulder scores (University of California, Los Angeles and Constant)

were significantly better than pre-operatively (p < 0.001) in both groups, although

no differences were found between the groups. The isometric elevation strengths

of the operated shoulders were equally good in both groups (p = 0.976) as well,

and no significant differences were observed between the operated shoulders and

non-operated shoulders at follow-up. The authors concluded that the use of a pain

pump after arthroscopic subacromial decompression did not have any long-term

effects on the patients' recovery, return to work, or final result at the minimum

2-year follow-up.

In a randomized, participant and outcome assessor-blinded, placebo-controlled

study, Coghlan et al (2009) examined the safety and effectiveness of ropivacaine

infusion following arthroscopic or mini-incision rotator cuff surgery. Subjects,

stratified by operative procedure (either arthroscopic decompression or rotator cuff

repair), were given preemptive 1 % ropivacaine (20 ml) and intra-operative

intravenous parecoxib (40 mg) and were randomly assigned to 0.75 % ropivacaine

or placebo by elastomeric pump at 5 ml/hr. Pain at rest was reported on a verbal

analog scale at 15, 30, and 60 mins and at 2, 4, 8, 12, 18, and 24 hrs. The use of

alternative analgesia, delay in discharge, and adverse events, including

development of stiff painful shoulder, infection, and leakage, were also assessed.

A total of 84 participants received arthroscopic decompression (43 in the placebo

arm and 45 in the ropivacaine arm) and 70 received rotator cuff repair (35

participants in each treatment arm). Compared with placebo, ropivacaine infusion

resulted in a significant but clinically unimportant improvement in average pain in

the first 12 hrs following both procedures (the average pain score was 1.62 and

2.16 for the ropivacaine and placebo arms, respectively, in the arthroscopic

decompression group and 2.12 and 2.82 in the rotator cuff repair group, with a

pooled difference between groups of 0.61; 95 % confidence interval [CI]: 0.22 to

1.01; p = 0.003). When adjusted for opioid use, the pooled difference between

groups was 0.49 (95 % CI: 0.12 to 0.86; p = 0.009). No difference was detected

between groups with regard to the maximum pain in the first 12 hrs or the average

or maximum pain in the second 12 hrs, with or without adjustment for opioid use,

and no difference was found between groups with regard to the amount of oral



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analgesia used. No difference was detected between groups with regard to the

prevalence of nausea and vomiting, catheter leakage, delayed discharge, or stiff

painful shoulder, and no subject in either group developed post-operative infection.

The authors concluded that there was minimal evidence to support the use of

ropivacaine infusion for improving outcomes following rotator cuff surgery in the

setting of preemptive ropivacaine and intra-operative parecoxib.

There is emerging evidence of a relationship between intra-articular administration

of chondrotoxic anesthetics and post-arthroscopic glenohumoral chondrolysis

(McNickle et al, 2009; Busfield et al, 2009; Saltzman et al, 2009; Bailie et al, 2009;

Hansen et al, 2007; Gomoll et al, 2006). Chondrolysis is characterized by the

complete loss of articular (or hyaline) cartilage, and is usually irreversible. The

chondrotoxic effects of anesthetics bupivicane and epinepherine are thought to

lead to cartilage damage.

At the request of the ORM subcommittee of the American Academy of Orthopaedic

Surgeons Medical Liability Committee, Morrell (2008) presented a paper on the use

of intra-articular continuous infusion pumps and chondrotoxicity. The author stated

that ideal post-operative analgesic protocol is one that results in the optimal control

of pain with the least exposure to side effects and risk of complications. Although

continuous infusion systems offer a certain degree of convenience, the ideal

delivery system and agent for intra-articular infusions have yet to be defined.

Furthermore, surgeons should not discount the value of pain, because pain is often

the first sign of an impending complication, and continuous infusion of local

anesthetics into a surgical site may mask that warning.

In a retrospective chart review, Andersen et al (2010) reported their experience of

patients who received infusion of bupivacaine with epinephrine after arthroscopic

glenoid labral repair surgery and in whom glenohumeral joint chondrolysis

subsequently developed, and determined the incidence of such chondrolysis in

their patient populations. A toal of 18 patients diagnosed with chondrolysis was

included in this study. All patients were from 2 experienced orthopedic surgeons'

practices. Details of their clinical course were obtained and summarized. These

data were compared with all other arthroscopies completed by the 2 surgeons to

determine the incidence of chondrolysis. All 18 patients diagnosed with

glenohumeral joint chondrolysis received post-operative infusion of bupivacaine

with epinephrine through an intra-articular pain pump catheter (IAPPC). None of

the patients received thermal energy as part of their procedure. None of the



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patients had evidence of glenohumeral joint infection, although an extensive work-

up was frequently undertaken. Clinically, patients presented with a stiff, painful

shoulder. Examination showed decreased range of motion of the affected

shoulder. Radiographs and magnetic resonance imaging showed joint space

narrowing, as well as subchondral sclerosis and cyst formation. Of the 18 patients,

14 had since undergone repeat arthroscopic procedures, and 5 have received a

humeral head-resurfacing operation. Within the same time period, there were 113

arthroscopies, with 45 pain pumps used. Chondrolysis developed in 16 of 32

patients with high-flow IAPPCs and 2 of 12 patients with low-flow IAPPCs (1

patient's IAPPC flow rate was not documented). The authors concluded that

although they can not establish a causal link, the development of glenohumeral

chondrolysis may be related to the intra-articular infusion of bupivacaine with

epinephrine post-operatively. Thus, they caution against the use of IAPPCs.

Chen et al (2010) examined if continuous intra-articular infusion of bupivacaine via

pain-control infusion pumps (PCIP) enhances and sustains analgesia after total hip

arthroplasty (THA). A total of 92 patients undergoing THA were randomized to

receive continuous intra-articular infusion of either 0.5 % bupivacaine or 0.9 %

normal saline at a flow rate of 2 ml/hr via a PCIP for 48 hrs. The primary outcome

measure was pain intensity on VAS scores in the first 72 hrs. Other measures

included time to first rescue dose of narcotics, amount of narcotic use, presence of

adverse events, length of hospital stay, and hip function evaluated with the

WOMAC index. Despite a longer time to first narcotic rescue (56 versus 21 mins, p

< 0.0001) in patients receiving bupivacaine, the 2 groups did not differ significantly

in overall pain relief (p = 0.54). A lower VAS score was found only at time 0 and 2

hrs; no difference in VAS score was noted at any other time point. Additionally, no

difference was found in terms of amount of narcotic use, incidence of adverse

events, hospitalization days, and the WOMAC score. The authors concluded that

continuous intra-articular infusion of 0.5 % bupivacaine at 2 ml/hr via a PCIP does

not provide sustained post-operative pain relief in patients undergoing THA.

Gottschalk and Gottschalk (2010) noted that continuous wound infusion of local

anesthetics, which is mainly used in general surgery and orthopedics, is an

interesting technique in post-operative pain therapy. Continuous wound infusion of

local anesthetics is able to reduce post-operative opioid requirements and results in

decreased pain scores. Recent studies indicate that rehabilitation seems to be

enhanced and post-operative hospital stay may be shorter. Continuous wound

infusion is an effective analgesic technique, which is simple to perform. Moreover,



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the authors stated that comparisons with other analgesic techniques (e.g.,

peripheral nerve blocks, epidural analgesia and other multi-modal analgesic

concepts) are still needed.

Scheffel et al (2010) reviewed the literature on glenohumeral chondrolysis to test

the hypothesis that common factors could be identified and that the identification of

these factors could suggest strategies for avoiding this complication. These

investigators identified 16 articles reporting 100 shoulders in which post-surgical

glenohumeral chondrolysis had developed. The average reported patient age was

27 +/- 11 years at the time of surgery; 35 were women. The most common

indications for surgery were instability (n = 68) and superior labrum antero-posterior

lesions (n = 17). In 59 cases, chondrolysis was reported to be associated with the

use of intra-articular pain pumps. The infusate was known to include bupivacaine

in 50 shoulders and lidocaine in 2. Radiofrequency capsulorrhaphy was performed

in 2 shoulders. Overall, 59 % of the reported cases of glenohumeral chondrolysis

occurred with the combination of arthroscopic surgery and post-arthroscopy

infusion of local anesthetic. The arthroscopic operations observed with

chondrolysis were not limited to stabilization procedures, and the infused anesthetic

was not limited to bupivacaine. The authors concluded that post-operative infusion

of local anesthetic and radiofrequency may not be essential to the success of

shoulder arthroscopy, surgeons may wish to consider the possible risks of their

use.

Furthermore, the FDA (2010) has reviewed 35 reports of chondrolysis in patients

who received continuous intra-articular infusions of local anesthetics with

elastomeric infusion devices (pain pumps) for post-operative pain management.

The local anesthetics involved entail bupivacaine, chloroprocaine, lidocaine,

mepivacaine, procaine, as well as ropivacaine with and without epinephrine. The

FDA stated that the significance of this injury to otherwise healthy young adults

warrants notification to health care professionals. The FDA is requiring the drug

manufacturers to update their product labels to warn healthcare professionals about

this potential serious adverse effect. It is also exploring possible options for

addressing the safety issues with the infusion devices.

In a recent review on the treatment of acute post-operative pain, Wu and Raja

(2011) stated that one concern with the infusion of local anesthetics intra-articularly

is the association of this technique with catastrophic chrondrolysis.



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In a double-blind, placebo-controlled study, Baulig et al (2011) quantified the impact

of continuous wound infusion with ropivacaine 0.33 % on morphine administration

and subjective pain relief in patients after open abdominal aortic repair. Before

closing the abdominal wound, 2 multi-hole ON-Q® Soaker Catheters™ (I-Flow

Corporation, Lake Forest, CA) were placed pre-peritoneally in opposite directions.

Either ropivacaine 0.33 % or saline 0.9 % was delivered by an elastomeric pump at

a rate of 2 ml/hr for 72 hrs in each of the catheters. Post-operative pain and

morphine administration were assessed using the numerical rating scale (NRS) in

4-hr intervals. Total plasma concentrations of ropivacaine, unbound ropivacaine,

and alpha-1-acid glycoprotein (AAG) were measured daily. Mean arterial pressure,

pulse rate, oxygen saturation, total amount of morphine administration, ventilation

time, and length of stay in the intensive care unit (ICU) were recorded. At the end

of the study period, the wound site and the condition of the catheters were

assessed. The study was terminated prematurely due to a malfunction of the

elastomeric balloon pump resulting in toxic serum levels of total ropivacaine in 2

patients (11.4 μmol/L and 10.0 μmol/L, respectively) on the second post-operative

day. Six patients had been allocated to the ropivacaine group, and 9 patients had

been allocated to the control group. Demographic and surgical data were similar in

both groups. During the first 3 post-operative days, no difference between the

ropivacaine and the control group was found in NRS (p = 0.15, p = 0.46, and p =

0.88, respectively) and morphine administration (p = 0.48). Concentrations of

unbound serum ropivacaine (0.11 +/- 0.08 μmol/L) were below toxic level in all

patients. The authors concluded that continuous wound infusion of ropivacaine

0.33 % 2 ml/hr using an elastomeric system was not reliable and did not improve

post-operative pain control in patients after open abdominal aortic surgery.

In a retrospective cohort study, Buchko et al (2015) examined the association

between post-operative intra-articular infusion of bupivacaine with epinephrine and

the development of knee chondrolysis in patients who have undergone arthroscopic

anterior cruciate ligament reconstruction (ACLR). These researchers hypothesized

that the development of knee chondrolysis after ACLR is associated with post-

operative high-dose intra-articular bupivacaine with epinephrine infusion. The

charts of all patients treated with arthroscopic ACLR by a single surgeon between

January 1, 2004, and December 31, 2006, were reviewed. Patients with severe

articular cartilage damage at the time of the index procedure, with known knee joint

infection, inflammatory arthritis, multi-ligament knee injury, bilateral knee injury, or

any previous knee surgery, were excluded. Patients were grouped into 2 cohorts:

(i) the exposure group (those who had post-operative infusion of bupivacaine



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with epinephrine via an intra-articular pain pump [IAPP]) and (ii) the non-

exposure group (those without post-operative infusion). A total of 105 patients

met the inclusion and exclusion criteria. There were 57 male and 48 female

patients with a mean age at surgery of 25.5 ± 8.6 years (range of 13 to 52 years).

The exposure group consisted of 46 patients and the control group of 59 patients;

13 of 46 patients (28.3 %) who received an IAPP developed chondrolysis. There

were no cases of chondrolysis in the control group. Of those in the exposure

group, 32 patients were exposed to 0.5 % bupivacaine with epinephrine and 12

developed chondrolysis (37.5 %), while 14 patients were exposed to 0.25 %

bupivacaine with epinephrine and 1 developed chondrolysis (7.1 %). Patients

exposed to 0.5 % bupivacaine with epinephrine had a significantly higher incidence

of chondrolysis compared with those exposed to 0.25 % (p = 0.03). Patients with

chondrolysis had severe pain and limitations in daily activity. The authors

concluded that the development of knee chondrolysis was associated with the intra-

articular infusion of bupivacaine with epinephrine post-operatively. Furthermore,

the presented evidence suggested that this occurs in a dose-dependent manner.

The risk of knee chondrolysis might be reduced by avoidance of intra-articular

infusion of bupivacaine with epinephrine. These investigators recommend against

continuous intra-articular infusion of local anesthetic post-operatively.

Ilfeld (2017) noted that a CPNB consists of a percutaneously inserted catheter with

its tip adjacent to a target nerve/plexus through which local anesthetic may be

administered, providing a prolonged block that may be titrated to the desired effect.

The current update is an evidence-based review of the CPNB literature published in

the interim. Novel insertion sites include the adductor canal, inter-pectoral,

quadratus lumborum, lesser palatine, ulnar, superficial, and deep peroneal nerves.

Noteworthy new indications include providing analgesia after traumatic rib/femur

fracture, manipulation for adhesive capsulitis, and treating abdominal wall pain

during pregnancy. The preponderance of recently published evidence suggested

benefits nearly exclusively in favor of catheter insertion using ultrasound (US)

guidance compared with electrical stimulation, although little new data are available

to help guide practitioners regarding the specifics of US-guided catheter insertion

(e.g., optimal needle-nerve orientation). After some previous suggestions that

automated, repeated bolus doses could provide benefits over a basal infusion,

there is a dearth of supporting data published in the past few years. An increasing

number of disposable infusion pumps does now allow a similar ability to adjust

basal rates, bolus volume, and lockout times compared with their electronic,

programmable counterparts, and a promising area of research is communicating



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with and controlling pumps remotely via the Internet. Large, prospective studies

now document the relatively few major complications during ambulatory CPNB,

although RCTs demonstrating an actual shortening of hospitalization duration are

few. Recent evidence suggested that, compared with femoral infusion, adductor

canal catheters both induce less quadriceps femoris weakness and improve

mobilization/ambulation, although the relative analgesia afforded by each remains

in dispute. Newly published data demonstrated that the incidence and/or severity

of chronic, persistent post-surgical pain may, at times, be decreased with a short-

term post-operative CPNB. Few new CPNB-related complications have been

identified, although large, prospective trials provided additional data regarding the

incidence of adverse events (AEs). In addition, the authors noted a number of

novel, alternative analgesic modalities are under development/investigation; and 4

such techniques were described and contrasted with CPNB, including single-

injection PNBs with newer adjuvants, liposome bupivacaine used in wound

infiltration and PNBs, cryoanalgesia with cryoneurolysis, and percutaneous

peripheral nerve stimulation.

Zhang and colleagues (2017) performed a systematic review and meta-analysis of

RCTs to evaluate the safety and effectiveness of local anesthetic infusion pump

versus placebo for pain management following TKA. In September 2016, a

systematic computer-based search was conducted in the PubMed, ISI Web of

Knowledge, Embase, Cochrane Database of Systematic Reviews; RCTs of patients

prepared for primary TKA that compared local anesthetic infusion pump versus

placebo for pain management following TKA were retrieved. The primary end-point

was VAS with rest or mobilization at 24, 48 and 72 hours and morphine

consumption at 24 and 48 hours. The secondary outcomes were range of motion

(ROM), LOS, and complications (infection, deep venous thrombosis (DVT),

prolonged drainage and post-operative nausea and vomiting (PONV)). A total of 7

clinical studies with 587 patients were included and for meta-analysis. Local

anesthetic infusion pump were associated with less pain scores with rest or

mobilization at 24 and 48 hours with significant difference. However, the difference

was likely no clinical significance. There were no significant difference between the

LOS, the occurrence of DVT, prolonged drainage and PONV. However, local

anesthetic infusion pump may be associated with more infection. The authors

concluded that based on the current meta-analysis, there is evidence to support the

routine use of local anesthetic infusion pump in the management of acute pain

following TKA. They stated that more RCTs are needed to identify the pain control

effects and optimal dose and speed of local anesthetic pain pump.



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Anesthetic Infusion Pump Following Open Inguinal Hernia Repair

In a meta-analysis, Wu and colleagues (2014) evaluated the effectiveness of local

anesthetic infusion pump following open inguinal hernia repair for the reduction of

post-operative pain. These researchers conducted a systematic review and meta-

analysis of RCTs that have investigated the outcomes of using an infusion pump for

delivering a local anesthetic contrasted to a control group for open inguinal hernia

repair. Pain was assessed from Day 1 to Day 5 following the surgery. The

secondary outcomes included analgesia use and post-operative complications.

These investigators reviewed 5 trials that totaled 288 patients. The analgesic

effects of bupivacaine (4 trials) and ropivacaine (1 trial) were compared with a

placebo group. The pooled mean difference in the score measuring the degree of

pain diminished significantly at Day 1 to Day 4 in the experimental group. Two

studies have reported that the number of analgesics required also decreased in the

experimental group. No bupivacaine-related complication was reported. The

authors concluded that the findings of this study revealed that applying a local

anesthetic infusion pump following inguinal hernia repairs was more effective for

reducing post-operative pain than a placebo. However, they stated that the findings

were based on a small body of evidence in which methodological quality was not

high. They noted that the potential benefits of applying a local anesthetic infusion

pump to hernia repair must still be adequately investigated using further RCTs.

Anesthetic Infusion Pump Following Bariatric Surgery

Cottam et al (2007) stated that the use of a bupivacaine pain pump has previously

been reported to lower costs to hospitals, while providing similar pain relief to opioid-

based patient controlled analgesia (PCA) pumps. However, these benefits have not

been investigated in laparoscopic bariatric surgery. These investigators prospectively

randomized 40 laparoscopic Roux-en-Y gastric bypass (LRYGBP) patients into 2

groups. The 1st group received the ON-Q bupivacaine pain pump placed subxiphoid

and radiating in both directions caudally beneath the lowest rib. The 2nd group was

treated with a meperidine PCA, which was initiated in the post- anesthesia care unit

(PACU) and discontinued at 06:00 hour the following morning. Both groups had

identical surgery, anesthesiologists, anesthesia protocol and post- operative nausea

prophylaxis. There were no significant differences between the groups with regard to

age, sex, pain scores, nausea scores, gas pain scores, anti- emetic use throughout

their stay, or opioid use in the PACU. However, there was a dramatic decrease in

opioid use between the 2 groups over the time interval from



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leaving the PACU to 06:00 hour (meperidine by PCA mean of 217 mg versus ON-Q

129 mg meperidine equivalents, p = 0.008). The authors concluded that the use of

a bupivacaine pain pump offered the opportunity to dramatically reduce the use of

opioids post-operatively in all bariatric patients by eliminating PCA. This change

could potentially reduce the incidence of respiratory failure from over-sedation,

while offering the same levels of pain control.

In a retrospective study, Bray et al (2007) evaluated the effectiveness of a local

anesthetic pain infusion pump in management of post-operative pain in

abdominoplasty patients. A total of 38 abdominoplasty patients with local anesthetic

pain pumps and 35 abdominoplasty patients without pain pumps were included in

this study. Pain pumps were loaded with 0.25 % or 0.5 % bupivacaine and infused

at a constant rate of 4 ml/hour. All patients were admitted post-operatively and

started on a narcotic PCA. Post-operative PCA narcotic use and pain scores were

recorded every 2 hours by the nursing staff. For the 1st 24 hours of post-operative

hospital stay, pain medication, pain scores, and anti-emetic use were determined

from the patients' charts. Hospital LOS was also reviewed. In the pain pump

group, there was a small but not statistically significant reduction in pain medication

use (2.65 versus 3.04 pain units) (p = 0.34). Interestingly, pain scores were higher

in the pain pump group but not significantly (2.73 versus 2.31) (p = 0.17). There

was no statistically significant difference in the use of anti-emetics (0.8 versus 0.6)

(p = 0.60). Hospital LOS averaged 2.2 days in the pain pump group and 2.5 days

in the group without pain pumps (p = 0.09). The authors concluded that the post-

operative use of pain pumps in abdominoplasty patients did not significantly

improve pain management. Moreover, they stated that further investigation into this

application of the pain pump is needed before recommending their routine use in

abdominoplasty patients.

In a RCT, Sherwinter et al (2008) performed determined the safety and

effectiveness of the On-Q pump delivery system for continuous infusion of intra-

peritoneal bupivacaine after laparoscopic surgery. A total of 30 patients undergoing

laparoscopic adjustable gastric banding were randomly assigned to one of two

groups. The treatment group received On-Q pump systems filled with 0.375 %

bupivacaine, while the control group received pumps filled with 0.9 % normal

saline. The pump's catheter was introduced intra-peritoneally, and bupivacaine or

saline was then delivered for the first 48 hours after surgery. Patient's subjective

pain scores were evaluated at preset intervals. In addition, shoulder pain,

morphine requirements, and anti-emetic requirements were tabulated. A



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statistically significant decrease in patient's subjective reports of pain by VAS was

noted in the On-Q group 1.8 +/- 1.93 versus control 3.5 +/- 2.4, p < 0.046 and

remained significant until the end of the study (48 hours). No statistical difference

was noted in shoulder pain, morphine requirements, or anti-emetic requirements at

any time-point. The authors concluded that this study was able to provide evidence

of significant reduction in post-operative pain as measured by subjective pain

scores with the use of continuous intra-peritoneal bupivacaine using the On-Q pain

pump system. Moreover, they stated that further investigation is needed to

evaluate the cost effectiveness of this technique.

Iyer et al (2010) noted that the continuous infusion of ropivacaine is effective in

controlling pain for a wide variety of surgical procedures and reducing opioid

adverse effects and dependency. The present study evaluated the effectiveness of

ropivacaine infusion using the I-Flow dual Soaker catheter system at the surgical

site for bariatric surgery recovery at the Dallas Veterans Affairs Medical Center

Hospital (Dallas, TX). These researchers hypothesized that patients receiving

ropivacaine would report lower levels of morphine requirement and pain, would

have shorter hospital stays, and would return to ambulating faster than patients in

the control group. A total of 45 patients undergoing Roux-en-Y gastric bypass

surgery were randomized to 1 of 2 treatment groups, with a target study population

of 50 patients, receiving either 0.2 % ropivacaine (n = 24) or saline solution (n =

21). Before incision closure, the surgeon infiltrated the surrounding tissues with 30

ml of ropivacaine (0.5 %) or saline solution. The catheter was then placed in both

the sub-fascial space and subcutaneously. Next, the infusion pump was connected

to the Soaker Catheters to complete the system design and deliver solution to the

surgical site. No significant differences were found in the pain scores, morphine

requirement, or LOS between the 2 groups. The ropivacaine group interval to

sitting up was 1/2 day shorter than that of patients receiving saline (p = 0.038). The

authors concluded that patients receiving ropivacaine were found to ambulate much

more quickly than did the control group patients. This could be very beneficial in

reducing the complications from blood clots and improving patient recovery and

overall well-being after surgery by assisting with a quicker return to activities of

daily living and reducing the dependence on the nursing staff.

Cohen et al (2013) examined if continuous delivery of local anesthetic via an

infusion pump system decreased post-operative opioid usage in post-RYGBP

patients. The electronic health record was used to identify and review 289 patients

who underwent RYGBP at the authors’ institution from January 2009 to October



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2011. The treatment group received a continuous infusion of 0.375 % bupivacaine

administered by intra-peritoneal soaker catheter for 48 hours via an infusion pump;

the control group did not receive a pump or local anesthetic. Both groups received

general anesthesia, nausea prophylaxis, and pain medication. Pain management

consisted of opioid-containing PCA for the 1st 24 hours. Patients transitioned to

supplemental intravenous opioid boluses, plus an oral opioid, for the remainder of

their stay. Opioid use was measured in terms of morphine equivalents; secondary

outcomes included VAS pain scores and LOS. Morphine equivalents over the post-

operative time-point studied were significantly lower in the bupivacaine group than

the control group (133 versus 106 mg, respectively; p = 0.001). There was no

significant difference in VAS scores between the 2 groups (p = 0.80). Finally, the

LOS between the 2 groups did not differ (p = 0.77). The authors concluded that

they have shown that continuous infusion of bupivacaine, administered via a pain

pump system, may have decreased post-operative opioid utilization. However,

there were no differences in VAS scores or length of hospitalization between

groups.

Medbery et al (2014) assessed the value of continuous wound infusion systems

(CWIS) in patients following (LRYGBP. Records of all consecutive patients who

underwent elective LRYGBP by a single surgeon from January 2008 until June

2010 were reviewed. The presence of CWIS, patient pain scores, PACU times, post-

operative narcotic and anti-emetic requirements, post-operative complications, and

hospital LOS were recorded. Clinical data were subsequently linked and correlated

with hospital financial data to determine overall hospital costs. A total of 44 LRYGBP

patients were reviewed; 24 (54.5 %) received CWIS for post-operative pain control.

There was no significant difference in PACU times, post-operative LOS, or post-

operative complications. Patients with CWIS required significantly less narcotics

(36.7 versus 55.5 mg IV morphine equivalents for total LOS; p = 0.03) and anti-

emetics (5.0 versus 12.4 mg ondansetron for total LOS; p = 0.02); however, patients

with CWIS did not report better pain control and had slightly higher hospital costs

($13,627.00 versus $13,395.05, p = 0.68). The authors concluded that findings from

the current study suggested that the value of CWIS for post-operative pain control

following LRYGBP is limited.

Furthermore, an UpToDate review on “Bariatric surgery: Postoperative and long-

term management of the uncomplicated patient” (Hamad, 2016) does not mention

infusion pain pump as a management tool.



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Anti-Emetic Infusion Pump

Second-line anti-emetics used in the treatment of nausea and vomiting during

pregnancy include chlorpromazine, droperidol, metoclopramide, ondansetron,

prochlorperazine, and promethazine (Smith et al, 2013). However, the use of these

anti-emetic agents by means of subcutaneous infusion pump is not established.

A review on “Nausea and vomiting in pregnancy” published in the Best Practice

Journal (BPJ, 2011) noted that “Nausea and vomiting are very common symptoms

of early pregnancy and usually resolve by 16 - 20 weeks gestation (most commonly

by 12 weeks). In most women these symptoms can be managed with simple diet

and lifestyle advice and reassurance that it will not have an adverse effect on

pregnancy. Women with more severe symptoms may require pharmacological

treatment and, in some cases, referral to hospital for intravenous fluids and

antiemetics”. Administration of anti-emetics by means of subcutaneous pumps was

not mentioned as a management option.

Reichmann and Kirkbride (2012) examined the medical evidence regarding the

clinical efficacy and cost-effectiveness of the application of continuous

subcutaneous metoclopramide and ondansetron to treat nausea and vomiting

during pregnancy. All of the published peer-reviewed articles on the subject were

assembled and assigned a level of evidence based on research design. The

search uncovered 1 level II matched, controlled trial and 3 level III uncontrolled,

retrospective case series published in peer-reviewed journals, as well as a book

chapter. The book chapter, although not subjected to the peer-reviewed process, is

included in this review due to the paucity of other evidence. The matched cohort

trial showed that continuous subcutaneous metoclopramide is significantly less-

tolerated than continuous subcutaneous ondansetron (31.8 % versus 4.4 %; p <

0.001). The 4 case series reported complete symptom resolution for 63.9 % to 75

% of the patients. Complications arose in 24.9 % to 30.5 % of the selected cases

that were severe enough to require discontinuation of therapy. Complications

included side effects of a worsening of symptoms. All of the trials were

retrospective and observational in nature and, therefore, subject to the limitations

inherent in the research design. Absent the benefit of meaningful cohort controls,

comparative statements effectiveness cannot be substantiated with the available

data. The authors concluded that randomized, controlled trials of sufficient power

are necessary before long-term continuous subcutaneous metoclopramide or

ondansetron can be used on a widespread basis to treat nausea and vomiting



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during pregnancy. Cost approximations in the case series were reported and,

when compared to the cost of other methods of treatment previously published in

the medical literature, the therapy appears to be cost-prohibitive. However,

definitive statements cannot be made regarding cost-effectiveness until clinical

efficacy is demonstrated through a sufficiently powered, well-designed RCT. Until

such time, the therapy should remain experimental; and coverage should be

restricted to intractable hyperemesis gravidarum that is unresponsive to more-

conventional treatment options.

An UpToDate review on “Treatment and outcome of nausea and vomiting of

pregnancy” (Smith et al, 2013) states that “The use of subcutaneous pumps for

timed release of medications, in particular metoclopramide, has been reported for

outpatient management of nausea and vomiting in pregnancy with some benefit.

However, the experience is limited; we do not use them”.

Ilfeld et al (2013) noted that there is currently no reliable treatment for phantom limb

pain (PLP). Chronic PLP and associated cortical abnormalities may be maintained

from abnormal peripheral input, raising the possibility that a continuous peripheral

nerve block (CPNB) of extended duration may permanently reorganize cortical pain

mapping, thus providing lasting relief. In a pilot study, 3 men with below-the-knee

(n = 2) or below-the-elbow (n = 1) amputations and intractable PLP received

femoral/sciatic or infra-clavicular perineural catheter(s), respectively. Subjects were

randomized in a double-masked fashion to receive perineural ropivacaine (0.5 %)

or normal saline for over 6 days as outpatients using portable electronic infusion

pumps. Four months later, subjects returned for repeated perineural catheter

insertion and received an ambulatory infusion with the alternate solution ("cross-

over"). Subjects were followed for up to 1 year. By chance, all 3 subjects received

saline during their initial infusion and reported little change in their PLP. One

subject did not receive cross-over treatment, but the remaining 2 subjects reported

complete resolution of their PLP during and immediately following treatment with

ropivacaine. One subject experienced no PLP recurrence through the 52-week follow-

up period and the other reported mild PLP occurring once each week of just a small

fraction of his original pain (pre-treatment: continuous PLP rated 10/10; post-

treatment: no PLP at baseline with average of 1 PLP episode each week rated 2/10)

for 12 weeks (lost to follow-up thereafter). The authors concluded that a prolonged

ambulatory CPNB may be a reliable treatment for intractable PLP. They stated that

the results of this pilot study suggested that a large, RCT is warranted.



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Schwartzberg et al (2013) evaluated the effectiveness of continuous subacromial

bupivacaine infusion to relieve pain after arthroscopic rotator cuff repair. These

researchers hypothesized that patients receiving continuous subacromial

bupivacaine infusions after arthroscopic rotator cuff repair will have less post-

operative pain in the early post-operative period than placebo and control groups.

A total of 88 patients undergoing arthroscopic rotator cuff repair were randomized in

a blinded fashion into 1 of 3 groups. Group 1 received no post-operative

subacromial infusion catheter. Group 2 received a post-operative subacromial

infusion catheter filled with saline solution. Group 3 received a post-operative

subacromial infusion catheter filled with 0.5 % bupivacaine without epinephrine.

Infusion catheters were scheduled to infuse at 4 ml/hr f or 50 hours. Post-operative

pain levels were assessed with VAS scores hourly for the first 6 post-operative

hours, every 6 hours for the next 2 days, and then every 12 hours for the next 3

days. Patients recorded daily oxycodone consumption for the first 5 post-operative

days. Immediately post-operative, the group with no catheter had significantly

lower VAS scores (p = 0.04). There were no significant differences in VAS scores

among the groups at any other time-point. There were no differences found among

the groups regarding mean daily oxycodone consumption. The authors concluded

that the use of continuous bupivacaine subacromial infusion catheters resulted in

no detectable pain reduction after arthroscopic rotator cuff repair based on VAS

scores and narcotic medication consumption.

Herring t al (2014) stated that regional nerve blocks provide superior analgesia over

opioid-based pain management regimens for traumatic injuries such as femur

fractures. An ultrasound-guided regional nerve block is placed either as a single-

shot injection or via a perineural catheter that is left in place. Although perineural

catheters are commonplace in the peri-operative setting, their use by emergency

physicians (EPs) for emergency pain management in adults has not been

previously described. Perineural catheters allow prolonged and titratable delivery

of local anesthetic directly targeted to the injured extremity, resulting in opioid

sparing while maintaining high-quality pain relief with improved alertness. Despite

these advantages, most EPs do not currently place perineural catheters, likely due

to the widespread perception that the procedure is both excessively time

consuming and too technically difficult to be practical in a busy emergency

department (ED). A catheter-over-needle kit, resembling a peripheral intravenous

line, is now available and may be familiar to EPs than traditional catheter-needle

assemblies. Recent studies also suggested excellent analgesic outcomes with

intermittent perineural bolusing of local anesthetic, thereby dispensing with the



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need for complex and expensive infusion pumps. The authors described their

successful placement of perineural femoral catheters at a busy inner-city public

hospital ED. They stated that their experience suggested that this is a promising

new technique for emergency pain management of acute extremity injuries.

Continuous Subcutaneous Anti-Emetic Pump

Dickman and colleagues (2017) stated that a continuous subcutaneous infusion

(CSCI) delivered via syringe pump is a method of drug administration used to

maintain symptom control when a patient is no longer able to tolerate oral

medication. Several classes of drugs, such as anti-emetics, anti-cholinergics, anti-

psychotics, benzodiazepines and opioids, are routinely administered by CSCI alone

or in combinations. Previous studies attempting to identify the most-common CSCI

combinations are now several years old and no longer reflect current clinical

practice. These investigators reviewed current clinical practice and identified CSCI

drug combinations requiring analysis for chemical compatibility and stability. United

Kingdom pharmacy professionals involved in the delivery of care to palliative

patients in hospitals and hospices were invited to enter CSCI combinations

comprised of 2 or more drugs onto an electronic database over a 12-month period.

In addition, a separate Delphi study with a panel of 15 expert healthcare

professionals was completed to identify a maximum of 5 combinations of drugs

used to treat more complex, but less commonly encountered symptoms unlikely to

be identified by the national survey. A total of 57 individuals representing 33

separate palliative care services entered 1,945 drug combinations suitable for

analysis, with 278 discrete combinations identified. The top 40 drug combinations

represented nearly 2/3 of combinations recorded. A total of 23 different drugs were

administered in combination and the median number of drugs in a combination was

3. The Delphi study identified 5 combinations for the relief of complex or refractory

symptoms. The authors concluded that this study represented the 1st step towards

developing authoritative national guidance on the administration of drugs by CSCI.

They stated that further work will ensure healthcare practitioners have the

knowledge and confidence that a prescribed combination will be both safe and

effective.

Anesthetic Infusion Pump for Local Wound Infusion Following Laparoscopic Cholecystectomy



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In a randomized, controlled, double-blind trial, Fassoulaki and colleagues (2016)

examined the effect of ropivacaine infusion on pain after laparoscopic

cholecystectomy. A total of 110 patients were randomly assigned to 2 groups.

After induction of anesthesia a 75-mm catheter was inserted subcutaneously and

connected to an elastomeric pump containing either 0.75 % ropivacaine

(ropivacaine group) or normal saline (control group) for 24 hours post-operatively.

Before skin closure, each hole was infiltrated with 2 ml of 0.75 % ropivacaine or

normal saline according to randomization. Pain at rest, pain during cough, and

analgesic consumption were recorded in the post-anesthesia care unit and at 2, 4,

8, 24, and 48 hours post-operatively. Analgesic requirements and pain scores were

recorded 1 and 3 months after surgery. The ropivacaine group reported less pain

during cough (p = 0.044) in the post-anesthesia care unit (p=0.017) and 4 hours post-

operatively (p = 0.038). However, ropivacaine wound infusion had no effect on late

and chronic pain.

Anesthetic Infusion Pump for Local Wound Infusion Following Cardiothoracic Surgery

In a retrospective, comparative analysis, Chopra and associates (2017) evaluated

the effectiveness of local anesthesia, delivered via elastomeric pump to manage

pain in patients undergoing cardiothoracic surgery. Subjects were adult

cardiothoracic surgery patients (by median sternotomy) who received continuous

infusion bupivacaine + traditional methods for pain control (n = 100) or traditional

pain control alone (n = 100) from July 2011 to October 2013. The primary end-

point was total post-operative opioid requirements for 96 hours following surgery;

secondary end-points included post-operative pain scores, non-opioid analgesic

requirements for 96 hours after surgery, and frequency of post-operative AEs.

Demographic characteristics were similar between both groups. No difference was

noted in overall opioid utilization for the 1st 96 hours post-operatively between the 2

groups (p = 0.36). Similar pain scores were reported by patients in both groups for

96 hours following surgery, with the highest pain scores reported during the 1st 24

hours following surgery (p = 0.37). No difference between groups was noted in

utilization of ketorolac or acetaminophen; frequency of post-operative AEs,

including the use of anti-emetic agents for nausea and vomiting, was similar in

between both groups. The authors concluded that the use of elastomeric pumps in

patients undergoing cardiothoracic surgery for reducing post-operative opioid

consumption and pain may not be as beneficial as previously reported.

Anesthetic Infusion Pump Following Unilateral Delayed Deep Inferior



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Epigastric Perforator Free Flap Reconstruction

Gatherwright and colleagues (2018) noted that effective post-surgical analgesia is a

critical aspect of patient recovery. In a prospective, randomized, controlled, blinded

study, these researchers examined the effect that liposomal bupivacaine delivered

via a transversus abdominis plane (TAP) block has on pain control in women

undergoing unilateral deep inferior epigastic perforator reconstruction. Patients

were eligible if they were undergoing unilateral, delayed DIEP reconstruction.

Patients were randomized to 1 of 3 groups: liposomal bupivacaine or bupivacaine

TAP block or bupivacaine pain pump. Charts were reviewed for demographics,

LOS, and post-operative narcotic utilization. There were 8 patients in the liposomal

bupivacaine and bupivacaine groups and 5 patients in the pain pump group. A

retrospective cohort of 6 patients who did not receive any intervention was

included. Patients who received a liposomal bupivacaine TAP block used

statistically significantly less intravenous and total post-operative narcotics in mg

and mg/kg/day compared to all other cohorts. They were able to get out of bed

earlier time point. Overall hospital costs were similar amongst the groups. The

authors concluded that this was the first study to investigate liposomal bupivacaine

delivered as a TAP block in a prospective, randomized, blinded study in women

undergoing unilateral, delayed abdominally-based autologous breast

reconstruction. These investigators were able to demonstrate a significant

reduction in intravenous and total narcotic utilization when a liposomal bupivacaine

TAP block was utilized. Moreover, they stated that future studies are needed to

prospectively investigate the effect that liposomal bupivacaine would have on

immediate and bilateral reconstructions.

Furthermore, UpToDate reviews on “Complications of reconstructive and aesthetic

breast surgery” (Nahabedian and Gutowski, 2018) and “Overview of breast

reconstruction” (Nahabedian, 2018) do not mention anesthetic infusion pump as a

management tool.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Other CPT codes related to the CPB:



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Code Code Description

19364 Breast reconstruction with free flap

32035 - 32999 Respiratory surgery, lung and pleura

33010 - 37799 Cardiothoracic surgery

43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass

and Roux-en-Y gastroenterostomy (roux limb 150 cmor less)

43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass

and small intestine reconstruction to limit absorption

43770 - 43775 Laparoscopy, surgical, gastric restrictive procedure

43842 - 43848 Gastric restrictive procedure

43886 Gastric restrictive procedure, open; revision of subcutaneous port

component only

43887 Gastric restrictive procedure, open; removal of subcutaneous port

component only

43888 Gastric restrictive procedure, open; removal and replacement of

subcutaneous port component only

47562 - 47564 Cholecystectomy

49491 - 49525 Repair, inguinal hernia

HCPCS codes not covered for indications listed in the CPB:

A4305 Disposable drug delivery system, flow rate of 50 ml or greater per hour

A4306 Disposable drug delivery system, flow rate of less than 50 ml per hour

E0781 Ambulatory infusion pump, single or multiple channels, electric or battery

operated, with administrative equipment, worn by patient [for

intralesional or intraarticular infusion of narcotic analgesics or

anesthesia] [continuous subcutaneous infusion of antiemetic drugs]

Other HCPCs codes related to the CPB:

C9290 Injection, bupivacaine liposome, 1 mg

J1240 Injection, dimenhydrinate, up to 50 mg

J1260 Injection, dolasetron mesylate, 10 mg

J1453 Injection, fosaprepitant, 1 mg

J1626 Injection, granisetron HCl, 100 mcg

J2405 Injection, ondansetron HCl, per 1 mg




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J2469

J2550

J2795

J3250

J3415

ICD-10 codes not covered for indications listed in the CPB:

I00 - I99.9

J00 - J99

M14.89

M25.9

M79.9

Z98.84

Numerous

options

Numerous

options

The above policy is based on the following references:


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0607 Anesthetic and

Antiemetic Infusion Pumps

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania updated 03/27/2019

http://www.aetnabetterhealth.com/pennsylvania

0607 anesthetic and antiemetic infusion pumps · 2020. 9. 3. · administration (fda) approval for...

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