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COMPARISION OF USE OF LEVOBUPIVACAINE WITH
DEXAMETHASONE VERSUS PLAIN LEVOBUPIVACAINE
IN PATIENTS UNDERGOING FOREARM SURGERIES
UNDER AN INFRACLAVICULAR BLOCK - A DOUBLE
BLINDED RANDOMIZED CONTROLLED TRIAL
Dissertation submitted to the Tamil Nadu Dr M.G.R. Medical University
in partial fulfilment of the requirement for the award of M.D.
(Anaesthesiology) degree April, 2017
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DECLARATION
I hereby declare that this dissertation titled “COMPARISION OF USE OF
LEVOBUPIVACAINE WITH DEXAMETHASONE VERSUS PLAIN
LEVOBUPIVACAINE IN PATIENTS UNDERGOING FOREARM
SURGERIES UNDER AN INFRACLAVICULAR BLOCK: A DOUBLE
BLINDED RANDOMIZED CONTROLLED TRIAL ” is carried out by me
under the guidance and supervision of Dr.Serina Ruth Salins, Associate
Professor in the department of Anaesthesiology, Christian Medical College,
Vellore.
This dissertation is submitted in partial fulfilment of the requirements for the
degree of MD Anaesthesiology examination of the Tamil Nadu
Dr.M.G.R.Medical University to be held in April 2017.
Vellore Dr.M.Anand Babu
Date: Reg No: 201520351
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CERTIFICATE
This is to certify that this dissertation, “COMPARISION OF USE OF
LEVOBUPIVACAINE WITH DEXAMETHASONE VERSUS PLAIN
LEVOBUPIVACAINE IN PATIENTS UNDERGOING FOREARM
SURGERIES UNDER AN INFRACLAVICULAR BLOCK: A DOUBLE
BLINDED RANDOMIZED CONTROLLED TRIAL”, is an original work of
research done by Dr.M.Anand Babu, Reg no. 201520351 that was carried out
under the guidance and supervision of Dr.Serina Ruth Salins, Associate
Professor in Anaesthesiology, Christian Medical College, Vellore towards
partial fulfilment of the requirements for the award of MD Anaesthesiology
examination to be held in April 2017.
Dr. Anna B Pulimood
Principal
Christian Medical College
Vellore
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CERTIFICATE
This is to certify that “COMPARISION OF USE OF LEVOBUPIVACAINE
WITH DEXAMETHASONE VERSUS PLAIN LEVOBUPIVACAINE IN
PATIENTS UNDERGOING FOREARM SURGERIES UNDER AN
INFRACLAVICULAR BLOCK – A DOUBLE BLINDED
RANDOMISED CONTROLLED TRIAL” is the bona fide work of Dr
Anand Babu M, reg No. 201520351 under my supervision in the Department
of Anaesthesia, Christian Medical College, Vellore in partial fulfilment of the
requirements for the M.D. Anaesthesiology Examination of the Tamil Nadu Dr.
M.G.R Medical University to be held in April 2017 and no part thereof has
been submitted for any other degree.
Signature of the Guide:
Dr.Serina Ruth Salins
Associate Professor
Dept of Anaesthesiology
Christian Medical College Hospital
Vellore 632004.
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CERTIFICATE
This is to certify that this dissertation, “COMPARISION OF USE OF
LEVOBUPIVACAINE WITH DEXAMETHASONE VERSUS PLAIN
LEVOBUPIVACAINE IN PATIENTS UNDERGOING FOREARM
SURGERIES UNDER AN INFRACLAVICULAR BLOCK: A DOUBLE
BLINDED RANDOMIZED CONTROLLED TRIAL”, is an original work of
research done by Dr.M.Anand Babu, Reg No. 201520351, that was carried out
under the guidance and supervision of Dr.Serina Ruth Salins, Associate
Professor in Anaesthesiology, Christian Medical College, Vellore towards
partial fulfilment of the requirements for the award of MD Anaesthesiology
examination to be held in April 2017.
Signature of the Head of the Department:
Dr. Sajan Philip George,
Professor and Head of the Department,
Dept of Anaesthesiology,
Christian Medical College Hospital
Vellore 632004
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PLAGIARISM CHECK
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Clinical Trial Registry of India
REF/2016/02/010691
From:
<http://ctri.nic.in/Clinicaltrials/submittrialmain.php?EncHid=66553.94830&mod
id=1&compid=12&tid=13692>
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ACKNOWLEDGEMENT
I would like to thank the Lord Almighty for enabling me accomplish this dissertation
and helping me out in each and every step.
I express my sincere and heartfelt gratitude to Dr.Serena Ruth Salins, Associate
Professor, Department of Anaesthesiology, Christian Medical College, Vellore for her
encouragement, support and guidance during the study.
I express my sincere and heartfelt gratitude to Dr. Rahul Pillai, Assistant Professor
Department of Anaesthesiology, Christian Medical College, Vellore for his support
and assistance throughout the study.
I thank Dr.Kalyana Chakravarthy, Associate Professor Department of
Anesthesiology, Christian Medical College, Vellore for his support.
I acknowledge my sincere gratitude to Dr.Samuel C Raj, Professor and Dr. Kiran,
Assistant Professor, Department of Hand and Reconstructive surgery, Christian
Medical College, Vellore for being a great support as a Orthopaedic surgeon and
giving us generous encouragement for the conduct of this study.
My sincere thanks to Dr Vinoo Matthew Cherian and Dr Tilak, from Orthopaedics
department, for their co operation throughout the study.
I express my sincere thanks to Mrs Gowri, Senior demonstrator, Department of
Biostatistics, Christian medical college, Vellore for helping me through the study
design and statistical analysis of this study.
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I am extremely grateful to Dr. S. Anna Durai, Professor & In charge, Manufacturing
division, Department of Pharmacy who did meticulous work in ensuring blinding and
randomisation of the study drugs.
I express my sincere thanks to Dr. Sajan Philip George, Professor and Head,
Department of Anaesthesiology, Christian medical college, Vellore for his support and
encouragement throughout the study.
I thank all my colleagues and anaesthesia technicians for their sincere and
overwhelming support at all stages of this study.
I thank all the patients who consented to be part of this study without whom it would
be impossible to do this study.
I would like to thank my friends Dr. Samuel and Dr. Khushboo for going an extra mile
in helping me to complete the thesis.
I would like to thank my wife Dr Annie Prasanthi without whom it would be
impossible for me to accomplish this task of dissertation and with whom it was made
an easy task.
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TABLE OF CONTENTS
DECLARATION ............................................................................................................ 2
CERTIFICATE ............................................................................................................... 3
PLAGIARISM CHECK ................................................................................................. 6
Clinical Trial Registry of India ....................................................................................... 7
LIST OF ABBREVIATIONS ...................................................................................... 14
List of figures ................................................................................................................ 15
LIST OF TABLES........................................................................................................ 16
ABSTRACT ................................................................................................................. 19
1. INTRODUCTION ................................................................................................ 21
2. AIMS AND OBJECTIVES .................................................................................. 24
3. REVIEW OF LITERATURE ............................................................................... 25
ANATOMY .............................................................................................................. 26
SENSORY AND MOTOR INNERVATION OF THE ARM ................................. 29
ASSESSING THE EXTENT OF BRACHIAL PLEXUS BLOCKADE ................. 30
ADJACENT STRUCTURES ................................................................................... 32
HISTORY ................................................................................................................. 32
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APPROACH TO BRACHIAL PLEXUS ................................................................. 34
INTERSCALENE BLOCK ...................................................................................... 35
CERVICAL PARAVERTEBRAL BLOCK ............................................................ 36
INTERSTERNOCLEIDOMASTOID BLOCK ....................................................... 36
SUPRACLAVICULAR BLOCK ............................................................................. 37
INFRACLAVICULAR BLOCK .............................................................................. 38
AXILLARY BLOCK ............................................................................................... 41
COMPLICATIONS .................................................................................................. 41
a. Peripheral Nerve Injury ............................................................................... 41
b. Mechanical Trauma ..................................................................................... 42
c. Ischemic Trauma ......................................................................................... 42
d. Chemical injury ........................................................................................... 43
LOCAL ANAESTHETICS ...................................................................................... 45
LEVOBUPIVACAINE ............................................................................................ 46
ADDITIVES OR ADJUVANTS .............................................................................. 50
DEXAMETHASONE .............................................................................................. 51
4. MATERIAL AND METHODS ........................................................................... 54
RANDOMISATION, ALLOCATION CONCEALMENT AND BLINDING: ...... 55
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INCLUSION CRITERIA: ........................................................................................ 56
EXCLUSION CRITERIA: ....................................................................................... 56
CONSENT: ............................................................................................................... 56
IMPLEMENTATION: ............................................................................................. 57
PRIMARY OUTCOME: .......................................................................................... 62
SECONDARY OUTCOME: .................................................................................... 62
SUMMARY OF METHODOLOGY ....................................................................... 63
SAMPLE SIZE CALCULATION: .......................................................................... 64
STATISTICAL ANALYSIS .................................................................................... 65
5. RESULTS ............................................................................................................. 66
DESCRIPTION OF BASELINE CHARACTERISTICS ........................................ 66
DATA OBTAINED DURING THE INTRA OPERATIVE PERIOD .................... 74
DATA OBTAINED IN THE POST-OPERATIVE PERIOD .................................. 88
6. DISCUSSION ....................................................................................................... 92
7. CONCLUSION .................................................................................................... 97
8. LIMITATIONS .................................................................................................... 98
9. Scope For Future Research: .................................................................................. 99
10. BIBLIOGRAPHY ............................................................................................ 100
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11. ANNEXURES .................................................... Error! Bookmark not defined.
Annexure 1: Institutional review board acceptance and fluid grant letter ............. 111
Annexure 2: Information sheet ............................................................................... 114
Annexure 3:Informed consent form ....................................................................... 115
Annexure 4: Informed consent in Hindi ................................................................. 116
Annexure 5: Patient information sheet in Hindi ..................................................... 117
Annexure 6: Patient information sheet in Tamil .................................................... 118
Annexure 6: Patient information sheet in Tamil .................................................... 118
Annexure 7: Informed consent form in Tamil ........................................................ 119
Annexure 8: PROFORMA of the study ................................................................. 120
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LIST OF ABBREVIATIONS
VAS VISUAL ANALOGUE SCALE
LA LOCAL ANAESTHETIC
GA GENERAL ANAESTHESIA
ASA AMERICAN SOCIETY OF ANESTHESIOLOGISTS GRADING OF
PHYSICAL STATUS
BMI BODY MASS INDEX
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List of figures
Figure 3.1: Anatomy of brachial plexus
Figure 3.2: Cutaneous sensory distribution of upper extremity (anterior view)
Figure 3.3: Cutaneous sensory distribution of upper extremity (posterior view)
Figure 3.4: mechanism of peripheral nerve injury
Figure 4.1: Ultrasound machine S-nerve
Figure 4.2:High frequency linear probe 13-6 MHz
Figure 4.3: sonoplex needle
Figure 4.4: ultrasound image - posterior cord
Figure 4.5: ultrasound image – lateral cord
Figure 4.6: ultrasound image – medial cord
Figure 4.7: flow chart of the study
Figure 5.1: range of age in both groups
Figure 5.2: ASA grading
Figure 5.3: distribution of study population
Figure 5.4: comparison of duration of surgery
Figure 5.5: frequency distribution of midazolam
Figure 5.6: frequency distribution of fentanyl
Figure 5.7: adequacy of surgical anaesthesia
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LIST OF TABLES
Table 5.1 General Demographic Characteristics Of Study Participants In Relation To
Drug
Table 5.2: Association Of Variables With Drug
Table 5.3: American Society Of Anaesthesiologists Grading Of Physical Status
Classification In Study Population
Table 5.4: Association Of ASA Grading And Drug:
Table 5.5: Frequency Distribution Of The Drug
Table 5.6 Comparison Of Duration Of Surgery In Both Groups
Table 5.7 Comparison Of Means And Standard Deviations (SD) Of Baseline
Characteristics
Table 5.8 Frequency Distribution Of The Midazolam
Table 5.9 Frequency Distribution Of The Fentanyl Administered
Table 5.10 Sensory Grading Of Radial Nerve
Table 5.11: Improvement Of Radial Nerve And Drug Association
Table 5.12 Association For Onset Of Anaesthesia And Drug In Radial Nerve
Table 5.13 Association For Onset Of Anaesthesia And Drug In Median Nerve
Table 5.14: Improvement Of Median Nerve And Drug Association
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Table 5.15 Association Between Onset Of Sensory Blockade And The Drug For
Median Nerve
Table 5.16 Association Between Onset Of Sensory Blockade And The Drug For Ulnar
Nerve
Table 5.17: Improvement Of Ulnar Nerve And Drug Association
Table 5.18: Association Between Onset Of Sensory Blockade And The Drug For
Ulnar Nerve
Table 5.19: Duration And Motor Grading Using Modified Bromage Scale
Table 5.20: Motor Grade Improvement And Drug Association At 5 Min
Table 5.21: Motor Grade Improvement And Drug Association At 20 Min
Table 5.22: Modified Bromge Scale Grading In Association With Drug
Table 5.23: Adequacy Of Surgical Anesthesia
Table 5.24: Association between Adequacy Of Surgical Anaesthesia And Drug Used
Table 5.25: VAS Score
Table 5.26: VAS Score In Relation To Levobupivacaine and Dexamethasone
Table 5.27: VAS Score In Relation To Levobupivacaine
Table 5.28: Supplementation of Aceclofenac In Study Population
Table 5.29: Aceclofenac Administration In Relation To Drug
Table 5.30: Supplementation Of Morphine In Study Population.
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Table 5.31: Association Of Morphine And Drug.
Table 5.32: Supplementation Of Paracetmol In Study Population
Table 5.33: Association of Paracetamol And Drug
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ABSTRACT
BACKGROUND: Regional neural blockade with local anaesthetic can reduce pain
following orthopaedic surgery and result in greater patient satisfaction. Injecting local
anaesthetic around the brachial plexus is useful in providing anaesthesia to patients
undergoing upper limb surgeries. Infraclavicular block has been proven to be safe to
perform and in efficacy compared to other approaches. Levobupivacaine is a long
acting local anesthetic which is an S( -) enantiomer of bupivacaine with less
cardiovascular and central nervous system toxic effects. Dexamethasone prolongs the
action of local anesthetics.
METHODS: This was a randomized controlled double blinded study approved by the
Institutional review board and ethics committee of Christian Medical College, Vellore.
This study was registered under clinical trial registry of India. Block randomization
was used. Study was done among the patients who underwent forearm orthopaedic
surgeries in Christian Medical College, Vellore between May 2016 to August 2016.
Inclusion criteria: Age between 18-70yrs posted for forearm surgery, ASA I-III,
weight greater than or equal to 50 kg. Exclusion criteria: Patients who are not willing
for the block, patient’s with coagulopathy, local infection over the block area,
pregnant women, patients requiring general anaesthesia, patient’s weighing less than
50kg, allergy to local anesthetic. A total of 40 patients of ASA (American Society of
Anaesthesiologist) preoperative risk classification I, II and III aged between18 years to
70 years were recruited in the study.
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STATISTICAL ANALYSIS: Data was summarized using mean (SD)/ median (IQR) for
continuous variables and frequency (percentage) for categorical variables. Independent
test/ranksum test (continuous) and chi-square (categorical) tests were used to compare the
baseline characteristics among the drugs. The outcome was defined as grade improvement
from 3min to 20min. A chi-square test was performed to compare the improvement among
drugs. A fisher exact test was used to compare the 3 min and 20 min grading among the drug
groups. All the significance levels were kept for p<0.05. All the statistical analysis was done
using stataic 13.1.
RESULT: In this study we assessed 45 patients for eligibility to be included in the study. 5
patients were excluded as some of them did not fulfill the inclusion criteria and for some
others there was a change in the operative plan on the day of surgery. Hence a total of 40
patients were recruited. Data collected from 40 patients was analyzed with 20 patients in one
arm and 20 patients in another arm.
CONCLUSION: There was no statistical difference in the onset of sensory and motor
blockade and in the duration of post-operative analgesia in the two groups: 0.5%
Levobupivacaine with Dexamethasone and 0.5% Levobupivacaine with normal saline added
in infraclavicular block in patients undergoing forearm orthopaedic surgeries. However there
was a significant improvement in sensory grading of median nerve and ulnar nerve between a
duration of 3 min and 20 min.(P value was 0.028 and 0.013 respectively) in the group with
0.5% Levobupivacaine with 4mg of dexamethasone in comparison with the group with 0.5%
Levobupivacaine with 1 ml of normal saline.
KEYWORDS: Levobupivacaine, Dexamethasone, Infraclavicular Block, Visual
Analog Score, Forearm Surgery
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1. INTRODUCTION
Severe post operative pain in orthopaedic upper limb surgeries remains a major
problem. It occurs in 20-40% of patients(1). Anesthesia for orthopaedic surgeries
involving upper limb can be provided by general anesthesia. Regional nerve blocks or
nerve blocks can supplement general anesthesia to provide intra operative and
postoperative analgesia and minimise the problems associated with general anesthesia.
Brachial plexus nerve block with local anesthetic provide an alternate for general
anesthesia for surgeries involving upper limb (2). Regional neural blockade with local
anesthetic can reduce chronic pain following orthopaedic surgery and result in greater
patient satisfaction (4). It provides longer duration of pain free period in the post
operative period (3).
The upper limbs of the body are supplied by a group of nerves. These nerves provide
sensation and movement to hand, forearm and arm. All these nerves arise from
brachial plexus. Injecting local anaesthetic around this brachial plexus is useful in
providing anaesthesia to patients undergoing upper limb surgeries. There are many
techniques of injecting local anaesthetic around the brachial plexus to provide
anaesthesia for surgery of the forearm. The brachial plexus can be approached with a
needle at various positions along its course. Some of the names of the techniques of
brachial plexus block are interscalene block (injection is given between a pair of
muscles called scalenus), supraclavicular block (injection above the collar bone),
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infraclavicular (injection below the collar bone) and axillary block ( injection at the
armpit ) and mid humeral technique ( injection at the mid arm region).
Infraclavicular block has been proven to be safe to perform and in efficacy compared
to other approaches(2). In experienced hands it reduces the complications and results
in better block (4). Ultrasound machine is used to identify the nerves and inject the
local anaesthetics. Alternately a machine called nerve stimulator is also in practice to
perform this procedure. Performing block under ultrasound guidance showed
superior results of successful sensory and motor blockade(5).
Local anaesthetics are a class of drugs that block the nerve action and prevent pain
and sensation when injected close to the nerves. There are many types of local
anaesthetic drugs with varied duration of action. Levobupivacaine a long acting local
anesthetic is an S( -) enantiomer of bupivacaine with less cardiovascular and central
nervous system toxic effects has been in clinical use for regional blocks since 20 yrs
(6).It provides equal efficacy to bupivacaine with lesser side effects(7). Increasing
dosage of local anesthetic is associated with increased incidence of systemic
toxicity(6). There are some ways to increase the duration of the action of the local
anaesthetics and prolong the time of pain relief. Pharmacological agents used as
adjuvants that increase the duration of local anesthetic action prolong the
postoperative analgesia of the patient during post operative period. Effective analgesia
is maintained during the postoperative period with the decreased use of opioid agents
(8,9). This also allows a continuous extended release of local anesthetic (10). One of
the drugs that prolong the action of local anesthetics is dexamethasone.
Dexamethasone improves the postoperative pain relief (3).
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Perineural dexamethasone prolonged the durations of analgesia and motor blockade
when used with local anaesthetics (8). Decreased nociceptive C-fibre activity via a
direct effect on glucocorticoid receptors and inhibitory potassium channels is probably
the mechanism of action of dexamethasone. Some authors suggest a local
vasoconstrictive effect which results in reduced local anesthetic absorption(11)
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2. AIMS AND OBJECTIVES
AIM:
The aim of this study is to compare the efficacy of Levobupivacaine with
dexamethasone versus plain Levobupivacaine in patients undergoing forearm
surgeries under an infraclavicular block of anaesthesia.
OBJECTIVES:
To compare the onset of sensory and motor blockade of 0.5% Levobupivacaine
with 4 mg dexamethasone and 0.5% Levobupivacaine with 1 ml of normal
saline added in infraclavicular block in patients undergoing forearm
orthopaedic surgeries.
To compare the duration of post-operative analgesia of 0.5% Levobupivacaine
with 4 mg dexamethasone and 0.5% Levobupivacaine with 1 ml of normal
saline added in infraclavicular block in patients undergoing forearm
orthopaedic surgeries.
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3. REVIEW OF LITERATURE
For surgeries involving extremity, regional anaesthesia is an excellent alternative to
general anaesthesia(12). Lower arm anaesthesia, from the elbow to the hand, may be
achieved promptly by injection of local anaesthetic around the brachial plexus(13). It
provides better analgesia in the post operative period and quicker recovery from the
anaesthesia. During the early postoperative phase of healing, sometimes post operative
analgesic duration is not adequate to compensate acute nociception associated with
surgery. In an effort to enhance post operative analgesia, many adjuvants like
clonidine, neostigmine, epinephrine, tramadol, buprenorphine and dexamethasone
have been added to local anesthetics (LA)(12,14). Several clinical studies have
evaluated the effectiveness of dexamethasone applied perineurally with local
anaesthetics in regional nerve blocks including epidural(15,16) brachial plexus (17),
femoral and sciatic(18) and facial and dental blocks (19). Alternatives used for
measuring postoperative pain (e.g., duration of analgesia, pain scores, opioid
consumption) appear to be improved by the addition of dexamethasone to LA agents
injected perineurally (20). Pain scores were lowered at 24 hours and 48 hours
postoperatively by adding dexamethasone to local anaesthetic, corresponding to less
opioid consumption over those 24– 48 hours. This opioid-sparing effect could result in
decreasing opioid-related noxious effects like nausea, vomiting, urinary retention,
constipation, pruritis and respiratory depression(12). Perineurally administered
dexamethasone added to local anaesthetic during the brachial plexus block delayed the
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latency and prolonged the recovery of motor block. This is similar to the analysis done
by Choi et al (21). The technique of brachial plexus block may result in
neurological complications including respiratory distress, Horner’s syndrome and
recurrent laryngeal nerve injury(22).
ANATOMY
The brachial plexus are a group of nerves that begin as spinal nerve roots and continue
as nerves to the end branches and supply the upper limb. The main purpose of the
brachial plexuses is to provide nerves supply to the upper limb but it also provides
sensory and motor branches to cervical and upper thoracic wall. The brachial plexus
origins as the accord of the ventral primary rami of cervical nerves 5 to 8 (C5–C8) and
a most of the first thoracic nerve (T1). Sometimes fourth cervical C4 vertebrae and
second thoracic nerve T2 contribute in the plexuses. (23). The roots of brachial
plexuses are the ventral rami. The brachial plexuses originate in neck and then
descend into the root of the neck, between the scalene muscles the nerve roots
coalesce and form trunks.
These trunks divides at clavicle into divisions i.e., anterior and posterior which again
coalesce and form cords and runs under the clavicle (collarbone) and in position to
the 2nd part of the axillary artery are classified as medial, lateral and posterior cords.
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The cords run through the axilla (armpit) and give rise to the nerves and down the
arm. The cervical rami C5 and C6 typically coalesce near the medial margin of the
middle scalene muscle and become the superior trunk of the brachial plexus; the C7
ramus gives rise to the middle trunk; and the lower cervical rami C8 and upper
thoracic rami T1 unite and form the inferior trunk. The absence of anterior tubercle
C7 transverse process, helps in ultrasonographic location of the C7 nerve root(24)
Through the interscalene groove the roots and trunks traverse. Interscalene groove is a
palpable surface and identification landmark between the anterior and middle scalene
muscles. At the lateral border of the first rib, each trunk divides individually and gives
anterior and posterior divisions.
Divisions reorganize into cords. Cords are defined by their relationship to the second
part of the axillary artery. The lateral cord is the result of the fusion of anterior part of
superior and middle trunks of the plexus, the posterior divisions of all trunks unite and
form the posterior cord; and the anterior division of the inferior trunk gives rise to the
medial cord. The three cords divide and give rise to the terminal branches of the
plexus. From each cord two main terminal branches and many small and
intermediary branches originate (23). Lateral cord gives rise to musculocutaneous
nerve and the lateral component of the median nerve. The dorsum of the upper limb is
supplied by the radial and axillary nerves which are the terminal braches from the
posterior cord. The ulnar nerve and the medial component of the median nerve arise
from the median cord.
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Figure 3.1: Anatomy of Brachial Plexus
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SENSORY AND MOTOR INNERVATION OF THE ARM
The knowledge regarding the cutaneous dermatomal distribution of nerves and the
nerve supply to the end branches is important in identifying the incomplete blockade
during surgeries and to identify whether the patient had preoperative neurological
deficit or postsurgical deficit. Understanding the sensory and motor supply is
important to elicit adequacy of anesthesia during block performance involving the
upper limb. The cutaneous supply of the upper limb arises from different spinal
segments. Motor supply can be elicited by using a peripheral nerve stimulator and
stimulation response to the nerve.
Figure 3.2 Cutaneous Sensory Distribution of the Upper Extremity (Anterior view)
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Figure 3.3 Cutaneous Sensory Distribution of the Upper Extremity (Posterior view)
ASSESSING THE EXTENT OF BRACHIAL PLEXUS BLOCKADE
Innervation of the arm comes from different nerves. Hence the extent of blockade is
best assessed by assessing the functions unique to each terminal nerve. A method of
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performing such an assessment is the 4 P’s(25). The patient is asked to push the arm
by extending the forearm at the elbow against resistance (radial nerve), this is
followed by resisting the pull of the forearm at the elbow (musculocutaneous nerve).
The ability to distinguish a pinch at the palmar base of the index finger assesses the
median nerve, whereas another pinch at the palmar base of the little finger evaluates
the ulnar nerve. Movement of the little finger during infraclavicular block (ICB) helps
in identifying which cord is being stimulated. With the arm adducted, movement of
the little finger medially toward the body indicates the stimulation of the medial cord,
whereas stimulation of lateral cord is by the lateral movement away from the body.
The posterior cord stimulation is identified by the posterior movement of the little
finger (26).
Peripheral nerves are made of a varying number of fascicles that consist of individual
nerve fibers (axons). These individual nerve fibres are contained within endoneurium.
Fascicles are enclosed within perineurium, while groups of fascicles are enclosed
within epineurium. As the nerve travels away from the spinal cord, the density of the
epineurium (stroma and connective tissue) decreases, but its total volume increases.
The amount of neural tissue remains stable.
Thus, the ratio of non neural to neural tissue contained within the epineurium
increases from 1:1 in the proximal plexus to 2:1 in the distal plexus. The cross-
sectional area of a peripheral nerve may consist of up to 70% loose connective
tissue(27). The clinical significance of this observation is that when a needle enters a
peripheral nerve by mistake, it does not always come to rest within a fascicle but may
instead lie within connective tissue.
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ADJACENT STRUCTURES
Vascular structures are very important anatomic landmarks and the structures to be
avoided while performing the block. The vertebral artery course forwards from its
origin in the subclavian artery. The cervical roots of the brachial plexus travel directly
posterior to the vertebral artery as they exit the intervertebral foramina(28). This
places the vessel at a potentially vulnerable site for intravascular injection, especially
if the needle courses anterior and medial to the anterior scalene muscle. The external
jugular vein usually overlies the interscalene groove at the level of C6. The subclavian
artery lies close to the brachial plexus as they travel over the first rib. Here, the
trunks/divisions of the brachial plexus lie posterior, cephalad, and ultimately lateral to
the subclavian artery(28). They form a reliable anatomic landmark during placement
of supraclavicular block(29). Nerve-vascular relationships change with the changes in
the arm position and during application of external pressure while performing the
block.
HISTORY
Halstead first performed brachial plexuses block using cocaine under direct
visualisation. Later on, Herschell described the percutaneous brachial plexus
block(54). Labat was the first to describe in his book of regional anaesthesia about
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infraclavicular block in 1922(55). The first description of a neurostimulation-guided
infraclavicular block was by Raj and colleagues in 1973(56). Whiffler (57) followed
in 1981 with his description of the technique using the coracoid process as the main
surface landmark, but it was not until Kilka and colleagues described their vertical
infraclavicular plexus block in 1995 that significance in the infraclavicular approach
really blossomed(54). Lateral sagittal infraclavicular block using MRI has shown to
be effective in measuring the depth and angle and success of block (58).
Since then several alternatives of the nerve stimulation guided infraclavicular block,
using slightly different surface landmarks, have been described and adopted into
clinical practice. Most recently, ultrasound-guided techniques of infraclavicular block
(49,59) in which the axillary artery and surrounding brachial plexus are directly seen
using ultrasound and have gain more importance . By allowing direct visualization of
the needle tip, target nerves and the spread of local anaesthetic as it is injected
ultrasound can improve the success of the block(60). Study conducted by Wu TJ et al
has shown the advantage of ultrasound guidance they were able to identify the nerves
segments and with ease performed the infraclavicular block (61). Sandhu et al
suggested deposition of the drug is accurate using ultrasound, the brachial plexuses are
seen in real time imaging where they observed the deposition of the drug around the
targeted nerves (62). Posterior parasagittal in plane approach using ultrasound by Zhi
Yuen et al suggested better success rate(63) .
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APPROACH TO BRACHIAL PLEXUS
There are many techniques of brachial plexus blockade that can be used to provide
anaesthesia for surgery of the lower arm. The brachial plexus may be approached with
a needle at various sites along its course. The ability to accurately localize a nerve or
plexus and successfully place local anesthetic around the structure is both an art and
science. The use of ultrasound for brachial plexus block helps the practitioner
visualize anatomy, needle placement and local anesthetic spread. The use of
ultrasound and the basic rules of safe regional anesthesia practice help in successful
and safe performance of brachial plexus block. The basic rules of safe regional
anesthesia include good training, knowledge of anatomy and careful technique
including slow injection of local anesthetic with regular syringe aspiration and
maintenance of verbal contact with the patient. These approaches include interscalene
block where the trunks are blocked (where the needle passes between the scalene
muscles after piercing the skin in the front of the neck); supraclavicular block, the
brachial plexus are blocked at the level of cords (where the skin is pierced in the root
of the neck above the clavicle lower and more laterally); infraclavicular block
functionally blocks the cords (where the skin is pierced in the area below the clavicle)
; axillary block (where the skin is pierced in the axilla) where the nerves are
anaesthetised and mid-humeral block (where the skin is pierced in the upper
arm)individual nerves are blocked.
35
The choice of which technique to use depends upon the practitioner’s preference, site
of the surgery, expected efficacy and safety of each technique(13).
INTERSCALENE BLOCK
Winne demonstrated land mark technique of interscalene block by identifying scalene
muscles at the level of cricoid and suggested the interscalene space is in contact with
subclavian perivascular space(30). Rochh et al proposed identification of paraesthesia
in the shoulder alone sufficient for drug administration and will result in successful
interscalene block (31). Some radiological studies have shown a higher volume of
drug can cause complete cervical and brachial plexuses block (32) .The perineural
space surrounding the brachial plexuses aids in the spread of local anaesthetic but
might not be spread evenly resulting in incomplete blockade(33) . The placement of
catheter straighter or angulated around the trunks for continuous interscalene block is
achieved better using modified lateral technique as demonstrated by Borgeat A (34)
As reported by Urmey et al, high occurrence of ipsilateral phrenic nerve blockade
with interscalene block is almost 100% under ultrasound guidance and also decrease
in the pulmonary function even with lesser volumes of local anesthetics (35). Incidents
of severe hypotension and bradycardia in patients undergoing awake shoulder surgery
occur due to stimulus from intracardiac mechanoreceptors in sitting position and this
36
response can be reduced by prior administration of beta blockers (36). Spread of the
drug into the epidural space and intrathecal administration is prevented with the
correct placement of the needle around a depth of 2.5 cm and an angulations at 50
degrees in caudal plane (37) .
This block should be avoided in deeply sedated patients and after administering
general anesthesia as intramedullary needle placement and cervical spinal cord injury
damage are reported to occur(38) .
CERVICAL PARAVERTEBRAL BLOCK
Cervical paravertebral block is mainly used for surgeries involving shoulder. Posterior
approach to the brachial plexus were popularised by Pippa et al and recently redefined
by Boezaart et al. There is less motor blockade (39) and a greater ease of perineural
catheter placement(40) with cervical paravertebral block as compared with traditional
interscalene approaches.
INTERSTERNOCLEIDOMASTOID BLOCK
The inter-sternocleidomastoid block (ISCMB) is used in the surgery of hand and arm.
In this technique the needle is directed laterally between the heads of the
sternocleidomastoid muscle(41). This technique is popularised for its ease of catheter
insertion and supposedly reduces the risk of pneumothorax.
37
SUPRACLAVICULAR BLOCK
Supraclavicular block, the brachial plexus at the level of cords is blocked (where the
skin is pierced lower and more laterally in the root of the neck above the clavicle).
Many approaches like classic approach of Kulenkampff , Winne’s subclavian
perivascular technique, modified lateral paravascular approach by Moorthy (42,43) are
published and in use .
Plumb-bob technique by Brown and Bridenbaugh’s is commonly used as it is
associated with less chance of pneumothorax(44) . To reduce the chance on
complications of vascular puncture and lung injury Klasttad et al proposed that initial
needle advancement should be directed cephalad with an 45 degree angulation and
then gradually move caudally. Identifying hand contraction while stimulating middle
trunk results in efficient block. Ultrasound enables faster implementation of
supraclavicular block and avoids sparing of ulnar nerve in comparison to nerve
stimulator and landmark technique(45). Identification of subclavian artery and bunch
of grapes is needed in an ultrasound approach. The volume of drug administered by
conventional landmark, using nerve stimulation or ultrasound should be same(46).
Pneumothorax is the most common complication associated with supraclavicular
block. Hemi diaphragmatic paresis is common. Its incidence in supraclavicular block
is 50% - 60% using nerve stimulator technique(47) while its occurrence is low using
ultrasound. Other complication is vascular injury to subclavian artery and transverse
cervical artery.
38
INFRACLAVICULAR BLOCK
The infraclavicular space is a pyramidal shaped and contains the brachial plexus,
subclavian-axillary artery and vein, and lymph nodes and loose fatty tissue .The apex
is a triangular surface. It is formed by the confluence of the clavicle, scapula and first
rib. The base of the triangle is formed by the skin and subcutaneous tissue of the
armpit. The posterior wall is formed by the scapula and its associated muscles and
their investing fasciae and the anterior wall by the pectoralis major and minor. The
lateral wall is constituted by humerus, and the converging muscles and tendons of the
anterior and posterior walls that insert into it.
The bony thoracic cage with its overlying layer of serratus anterior muscle and fascia
forms the medial wall. At the level of the infraclavicular space the brachial plexus is
organized as three cords (lateral, medial and posterior) surrounding the axillary artery.
The infraclavicular block targets the brachial plexus in the infraclavicular space.
Infraclavicular block functionally blocks the cords (where the skin is pierced in the
area below the clavicle).
None of the major terminal branches arise at this level(13). The purported advantages
of infraclavicular block are as follows. First, it provides complete anaesthesia of the
upper limb because it blocks the brachial plexus at the place where the three cords run
close together in a neurovascular bundle with the axillary artery. The axillary block
often fails to block the axillary nerve and musculocutaneous nerves, while the
39
interscalene and supraclavicular approaches may often fail to grant anaesthesia in the
distribution of the ulnar nerve. There also appears to be a lower incidence of
tourniquet pain with the infraclavicular block. This is attributed to spread to the
intercostobrachial nerve that runs close to the brachial plexus in the infraclavicular
space(48,49). Secondly, the risk of unintended lung or pleural puncture is lower than
with the interscalene and supraclavicular approaches as the lung does not lie in the
path of the needle. Thirdly, by piercing the skin below the clavicle, injury to the other
neurovascular structures in the neck are avoided (unlike with the interscalene or
supraclavicular approaches). Fourthly, infraclavicular block does not require
abduction of the arm at the shoulder can be performed in any arm position and neck
position need not be changed. Finally, it is an ideal site for inserting a catheter for
continuous infusion of local anaesthetic.
The bulk of the pectoralis muscle firmly anchors the catheter, arm movement is not
impaired and hygiene is easily maintained(50).
Tourniquets are frequently used in orthopaedic surgeries to give relatively a clear field
for operation and to reduce overall blood loss. Tourniquet pain is a common
complication associated. Tourniquet pain may occur in around 66 percent of the
patients following approximately one hour after cuff inflation. The probable
underlying pathophysiology for tourniquet pain is both mechanical compression and
ischaemia of the nerve. During local anaesthetic induced conduction blockade, small
unmyelinated C fibres are more resistant in comparison to large myelinated A fibres.
40
Hence as the concentration of local anaesthetic comes down, the C fibres begin to
conduct impulses earlier. As a result dull tourniquet pain occurs (61).
The decrease in tourniquet pain has been attributed to local anaesthetic spread to the
intercostobrachial nerve. This arises from the second thoracic nerve root and runs
through the axilla in close proximity to the axillary vein and infraclavicular space to
supply part of the medial surface of the upper arm (49). The infraclavicular block was
also faster to perform than the multiple-injection techniques of axillary block and
midhumeral block, by an average time difference of three and five minutes
respectively. This advantage is slightly offset by the increased sensory block onset
time observed with infraclavicular block. The overall complication rate of the
infraclavicular block was low and no different from that observed with the other
blocks. Exclusively there were no case reports of pneumothorax.
The risk of Horner’s syndrome was also significantly reduced with the infraclavicular
block approach. Vascular puncture was the most commonly observed complication of
infraclavicular block due to the proximity of the axillary artery and vein to the brachial
plexus. This is in view of high risk patients with coagulation abnormalities as the
axillary vessels are deeply placed in the infraclavicular region may make it harder to
achieve haemostasis by compression(13). But with the advent of ultrasound guidance
the risk of vascular penetration is significantly reduced.
41
AXILLARY BLOCK
Axillary block is commonly indicated for hand, elbow and forearm surgeries. Axillary
artery is the landmark for axillary block. The neurovascular bundle is oriented around
the axillary artery. Median nerve is above axillary artery, ulnar nerve is below and
radial nerve is posterior or lateral to axillary artery. Axillary block effectively blocks
median nerve, ulnar nerve and radial nerve. It fails to block musculocutaneous and
intercosto brachial nerves as they course away from the axillary artery and leave the
brachial plexus at the level of coracoid process. Musculo cutaneous nerve can be
blocked by injecting into the coracobrachialis muscle. Radial nerve identification is
very crucial in the success of the block as it is deepest and difficult to access.
Deposition of local anaesthetic around the axillary artery results in successful block
(62).
COMPLICATIONS
Brachial plexus blockade is associated with complications like seizures, cardiac arrest,
death and radiculopathy.
a. Peripheral Nerve Injury
Peripheral nerve injury is an uncommon problem during regional anesthesia. It can
present as numbness, reduced sensation or rarely as paresis (64). Timing of
presentation of nerve injury is variable. Considerable part of injuries is evident during
the early postoperative period. Reason for immediate presentation of the neurological
deficits within the first 24 hours is mostly due to haematoma, edema of the nerve or a
42
lesion involving a significant number of axons. Delayed symptoms may present weeks
after surgery. Cause for delayed neuropathy is probably due to tissue reaction or scar
formation resulting in degeneration of nerve fibre or due to pain or immobility in the
perioperative period. Many factors contribute for nerve injury in the peri operative
period.
Unrelated risk factors to anesthesia include patient and surgical issues. Mechanical
trauma, ischemic injury, or chemical injury contribute to anaesthesia related nerve
injury and are directly related to regional anesthetic factors.
b. Mechanical Trauma
Rice and McMahon (68) reported that long-bevelled needles in the parallel
configuration caused less neuronal damage in comparison with transverse long- or
short-bevelled needles. This finding was seen instantly after injury and at 7 days later
also. Injuries caused due to long-bevelled needles were slowly resolving whereas
those caused by short-bevelled needles showed signs of severe injury. Neural repair
may be accelerated and more structured with long-bevelled injuries. Hence long term
consequences are less concerning(68).
c. Ischemic Trauma
Failure of blood flow to primary afferent nerve causes metabolic stress.
Microcirculation of peripheral nerve consists of blood vessels within the endoneurium
and an extrinsic supply of larger, non nutritive vessels(69).The function of a peripheral
nerve is very much reliable on its microcirculation. Extrinsic blood supply is
responsive to epinephrine. Epinephrine may aggravate nerve injury if there is a barrier
43
disruption. Barrier disruption of the nerve may occur due to intraneural injection(70)
or due to chemotherapy-induced neurotoxicity, atherosclerosis or diabetic
neuropathies(71). Intrafascicular injection of local anesthetic may also cause ischemic
nerve injury(70). This may cause degeneration and dystrophy of axon. Later fibroblast
proliferation occurs at the injury site. These changes may cause delayed tissue reaction
or scar formation. As a result symptoms of neurological injury may manifest days to
weeks after the peripheral nerve blockade.
d. Chemical injury
Local anesthetic can cause severe degenerative changes leading to neurological
sequelae when inappropriately high concentrations are used, when nerves are exposed
for a prolonged time or when intraneuronal injections are encountered(70). The
neurotoxic effects of local anesthetics are concentration-dependent(72). Acute-phase
(48 hrs) effects usually resolve completely within 10 to 14 days (73).
According to Cochrane review(13), infraclavicular block (ICB) is as effective as other
techniques of brachial plexus blockade for providing surgical anaesthesia of the lower
arm. The average success rate of this technique was found to be 88%. Subgroup
analysis by method of nerve localization (ultrasound or neurostimulation) and by the
different comparator block techniques shows that infraclavicular block maybe a
superior technique compared to the single-injection axillary block; as there was
significantly lower risk of requiring general anaesthesia and of failing to achieve
sensory block of the musculo cutaneous nerve with infraclavicular block. Increased
accuracy of local anaesthetic injection encompassing the brachial plexus by
ultrasound resulted to both the outcomes which were; no difference in the risk of
44
requiring supplementation and the mean difference in onset time between an
infraclavicular block and all other blocks, while still statistically significant, has also
decreased from 3.9 to 1.9 minutes.
Figure 3.4 Mechanisms of Peripheral Nerve Injury.
45
Direct Needle Trauma can rarely tear and Injure a Nerve (A) Or, More Commonly,
Injure the Perineurium (B) And Thereby Expose the Axons to Potential Local
Anesthetic Neurotoxicity (Shaded Area)
LOCAL ANAESTHETICS
Local anaesthetics are the drugs that block the conduction of action potential by
reversible action on voltage gated sodium channels on nerves. Local anaesthetics
exert their analgesic and anaesthetic properties by reversible blockade of neuronal
Sodium channels. Myelinated fibres are more readily blocked by action of local
anaesthetic at the nodes of Ranvier than unmyelinated fibres. Small nerves are more
easily blocked than large nerves(74). The prolonged duration of action is due to
delayed absorption into axonal cytoplasm(75). Local anaesthetics are tertiary amine
with aromatic ring in between connected by an ester or an amide. Local anaesthetics
are basically classified as amide or esters. Few examples of esters are cocaine,
procaine etc and amides are lignocaine, bupivacaine etc . The properties of the local
anaesthetics depends mainly on liphophilic hydrophobic nature and dissociation
constant i.e hydrogen ion concentration. The more the hydrophobicity the more
effective and acts for longer duration. Local anaesthetics can be used as topical,
46
infiltration, intravenous ,in peripheral nerve blocks and in central neuraxial
anesthesia. Lidocaine was the most commonly used and has been the first amide
local anaesthetic. It has fast to intermediate onset of action and intermediate duration
of action . Because it can cause transient neurological symptoms its use is reduced.
Bupivacaine is an amide local anaesthetic. It has a structure similar to Mepivacaine
with butyl group. Its pKa is 8.1 and more lipid soluble and highly protein bound. It
has slow onset of action and prolonged duration, requirement of repeated
administration of local anaesthetic and top doses are avoided. In low concentrations,
it predominantly causes sensory blockade and minimal motor blockade and provides
effective analgesia. There were many reported cases where accidental intravenous
injection of bupivacaine resulted in cardio toxicity and deaths . Bupivicaine has 2
stereoisomer S- and R+ ,the R isomer is proven to be associated with the cardio toxic
effects of bupivacaine(76) . Ropivacaine and Levobupivacaine are the S- isomers of
bupivacaine Levobupivacaine is a pure S(-)- enantiomer of racemic bupivacaine .
It is developed as an alternative anesthetic drug to bupivacaine. It was developed
with a purpose of achieving lower risk of cardio toxicity than bupivacaine.
LEVOBUPIVACAINE
Levobupivacaine (Chirocaine) is a long-acting amide local anaesthetic belongs to the
47
Family of n-alkyl substitute pipecoloxylidide with chemical formula C18H28N2O.
It has a dissociation constant of 8.1 which determines the physiology and mechanism
of action of block. Mechanism of action of Levobupivacaine and its pharmacologic
properties are similar to bupivacaine it acts mainly by reversible inhibition of Sodium
channel. It attaches intracellularly and blocks the influx of sodium and there by
prevents nerve condition. Its pharmacokinetic properties like protein binding and
plasma clearance are greater where as volume of distribution and t1/2 beta are less
compared to its racemic Bupivacaine(77). Levobupivacaine is mainly protein bound
97% it attaches mainly to alpha1 glycoprotein .The route of administration and the
amount of drug determines plasma concentration absorption mainly depends upon the
blood supply of the tissue . Absorption of the drug into epidural space is biphasic
smaller amounts reaches the blood earlier while the other portion reaches little slower
the peak concentration is reached after 30 min of administration. Epidural absorption
of the drug is influenced by age absorption is much slower in older as compared to
adults. Levobupivacaine is eliminated unchanged mainly through kidney and
gastrointestinal system. Levobupivacaine have been used as intrathecal in comparison
with bupivicaine and was proven to be statistically significant in providing surgical
anaesthesia in caesarean section(78) .
Alley and et al found that sensory and motor block were similar between the same
doses of bupivacaine and hyperbaric Levobupivacaine(79). Intrathecal administration
of Levobupivacaine and racemic Bupivacaine didn’t show any variation in
hemodynamic variables and in their potency also any difference in the time of onset of
sensory block and duration of motor block. Waning of motor block is earlier in
48
Levobupivacaine(80). Adequate surgical anaesthesia was achieved with
Levobupivacaine administered as intrathecal in children between age groups of 1-14
yrs. Post operative pain score and rescue analgesic requirements are similar in major
orthopaedic surgeries when Levobupivacaine in spinal anaesthesia (81) .
Levobupivacaine used for epidural anaesthesia has similar onset time, spread of drug
, and motor block its efficacy was similar when equal doses of drug is used in
comparison to bupivacaine .(82) Its efficacy for caesarean anaesthesia is shown to be
adequate when 25 ml either of the drug is administered both were satisfactory in
terms of sensory and motor blockade, cephalad spread even though motor block to the
limbs is for longer duration in Levobupivacaine group (83). Fetal and maternal plasma
concentrations of the drug was assessed using umbilical vein to maternal vein after
drug was administer for caesarean anaesthesia and found out no difference in
maximum concentration of the drug between two drugs (84). Increase in the
concentration of the drug is associated with more hypotension and increase in the
duration of sensory blockade and also time of regression of the block(82) .Both
Levobupivacaine and bupivacaine exhibits hypotension when similar doses are
administered for caesarean epidural anaesthesia. Levobupivacaine when used in
Thoracic epidural for intraoperative and postoperative analgesia was found to
effective as bupivacaine (85) .
Levobupivacaine has been safely used in vascular surgery in high risk elderly patients
in lumbar epidural anaesthesia ,addition of adjuvants prolonged the duration of
sensory and motor blockade and regression of block was also prolonged(86) . Its
effectiveness is supported in epidural and peripheral nerve blocks as prolonged
49
infusions providing suitable anaesthesia and pain relief in knee arthroplasty (87) .
Levobupivacaine is used in retro bulbar anaesthesia associated with appropriate
anaesthesia(88) . It can be used as bolus or continuous infiltration. It is generally well
tolerated and useful alternative to bupivacaine(89). Different additives have been used
to prolong regional blockade. Bupivacaine binds with Na channels in both activated
state and inactivated state and shows greater selectivity and faster towards the open
Na channels which is responsible for its cardiac inhibitory activity and toxicity where
as Levobupivacaine doesn’t show any selectivity explains the less cardio toxicity(90) .
Levobupivacaine ‘s three dimensional structure is the reason for less cardiac and
CNS toxicity(91) it’s an left isomer of bupivacaine with smaller difference in their
potency .Widening of QRS complex and severe arrhythmias are less in
Levobupivacaine compared to bupivacaine as published by Mazoit et al in a rat study
(92).
Graf et al studied the electrophysiology in isolated heart using bupivicaine and its
optical isomers and identified bupivacaine produces prolonged AV conduction delay
and secondary AV block in comparison to Levobupivacaine(93) .Huang YF et al
studied the toxicity of Levobupivacaine and bupivicaine in sheep .
The drug was injected intravenously at a graded doses 75mg and more incremental
doses and concluded that Levobupivacaine exhibits less toxicity than
bupivacaine(94). Many studies reported that Levobupivacaine provided longer
duration of analgesia than Ropivacaine in surgeries involving upper limb.
50
ADDITIVES OR ADJUVANTS
Pain involves complex pathway systems and is mediated by the neurotransmitters and
is transmitted to the central and peripheral nervous systems .It is blocked to an extent
by one drug like local anaesthetics or block technique. Search for combination of
drugs has started in the early 1900’s to provide a better blockade. Matas tried
combining morphine to cocaine during spinal anesthesia to prolong the action of
cocaine and for sedation. Later on, after the identification of opioid receptors on the
spinal cord in 1970, the use of opioids have become very popular and became a part
of routine practise. The purpose of adjuvants is mainly to increase the speed of onset,
prolong the duration of action of local anaesthetics and reduce the total amount of
drug. Adjuvants augment the postoperative analgesia with fewer side effects and also
should act mainly on the peripheral sites with less of central side effects like cardiac,
nervous and respiratory systems. Mechanism of action of adjuvant is by modulation of
A delta and C fibres in the spinal cord and thereby provides spinal analgesia(95).
Epidural administration of opioids resulted in delayed onset of anesthesia and did not
decrease the requirement of volatile anaesthetics. Perineural administration of opioids
may not reach the effect site by axonal transport there by its effects are minimal in the
peripheral nerves (96).
Only Tramadol and combination of Buprenorphine with tramadol have shown to be
effective in peripheral nerves and are in use. Vasoconstrictors are most commonly
used as adjuvants in spinal anaesthesia. It reduces the peak blood levels and provides
more consistent block with better analgesia and anaesthesia (97).Use of epinephrine
resulted in decrease in amount of local anaesthetics and there by local anaesthetic
51
toxicity. Epinephrine causes dose related effects at lower doses. Its effects are mainly
due to beta action at higher doses. It causes vasoconstriction mainly by alpha receptors
resulting in a decrease in blood supply and reduced uptake of local anaesthetics into
the circulation. At higher doses it can cause arrhythmias(98).
Clonide, an alpha 2 agonist has been used as an adjuvant. It has local anaesthetic
properties and its action is mediated by inhibition of C fibres. Clonidine when used in
peripheral nerves doses up to of 1.5mcg/ml and prolongs sensory block and duration
of analgesia(99). However recent studies recently has shown that the addition of
clonidine to long acting local anaesthetics like bupivacaine and Ropivacaine did not
benefit overall effect(100).
DEXAMETHASONE
Dexamethasone is a high-potency, long-acting glucocorticoid with little
mineralocorticoid effect. It has been shown to prolong peripheral nerve blockade in
animals and, when added to bupivacaine microspheres, to extend the duration of
analgesia in humans(8). The analgesic potency of corticosteroids is not fully
understood The analgesic effects of spinal and systemic corticosteroids in addition
with local anaesthetics in human studies have been recognised, whereas
dexamethasone microspheres have increased blockade duration in both human and
animal studies (101,102).
Furthermore, dexamethasone has been shown to possess an anti-inflamatory
action(103). Steroids produce vasoconstriction, so they reduce local anaesthetic
absorption. They adhere to the intracellular receptor to alter nuclear transcription. Stan
52
et al. (104)argued that the steroid suppresses the production and secretion of various
inflammatory mediators, which prolongs the period of analgesia up to 48 hours, and
Attardi et al.(105) showed that dexamethasone act on glucocorticoid receptors, which
increase the activity of inhibitory potassium channels on nociceptive C-fibers,
decreasing their activity. Other postulated mechanism of action of dexamethasone
include suppression of ectopic neural discharge and suppression of neuropeptide
immune response to injury(106).
The addition of dexamethasone to local anaesthetic administration in order to prolong
analgesia duration has recently been explored. Tandoc et al., has investigated low-
dose dexamethasone, but this was added to large dosages of bupivacaine for
interscalene blockade(107). This study concluded that addition of dexamethasone to
bupivacaine appreciably prolonged the duration of the motor block and improved the
quality of analgesia following interscalene block. There was no variation in the length
of analgesia and motor block between low-dose and high-dose dexamethasone. Persec
did a randomized controlled study in which he concluded that, using single-shot low-
dose dexamethasone in a mixture with Levobupivacaine causes long lasting analgesia
duration and less analgesic use compared with Levobupivacaine(108). Dexamethasone
was shown to extend the analgesia time when added as an adjuvant to local
anaesthetics for different blocks and administration routes.
In a prospective, randomized, double-blind study by Naghipour et al performed on 72
patients(16), 8 mg dexamethasone administrated via the epidural method prolonged
the analgesia time by two hours. Parrington etal(109) observed the same effect of
dexamethasone in a block of the supra clavicular brachial plexus as 104 minutes.
53
According to a meta-analysis, adding perineural dexamethasone for brachial plexus
blocks similarly did not alleviate against the development of these complications as
the incidence of dyspnoea, hoarseness and Horner’s syndrome were shown to be alike
in both control an dexamethasone treated groups(12). In a study of Holte et al(110) on
volunteer patients, dexamethasone was added to bupivacaine microcapsules by
subcutaneous infiltration to obtain 50 μg in 10 ml, and a significant increase in
analgesia time was observed. The randomized controlled, double blinded study done
by Akkaya etal (111)showed that: the time before the administration of the first
additional analgesic dose was prolonged significantly (p=0.004), the pain scores were
lower for superficial pain and deep pain and reduction of total additional analgesic
substances required in the dexamethasone group compared to the Levobupivacaine
group .
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4. MATERIAL AND METHODS
The proposal for the study titled “A randomized, controlled, double blind, prospective
study comparing Levobupivacaine with dexamethasone versus plain Levobupivacaine
in patients undergoing forearm surgeries under an infraclavicular block” was reviewed
and approved by the Institutional review board and ethics committee of Christian
Medical college, Vellore. After the approval of the institutional review board, the
study was registered under clinical trial registry of India. The aim of the study was to
compare the onset of sensory and motor blockade and the duration of post operative
analgesic efficacy with plain 0.5% Levobupivacaine against 0.5% Levobupivacaine
with 4mg dexamethasone added in infraclavicular block in patients undergoing
forearm orthopaedic surgeries.
INTERVENTION AGENT: 0.5% Levobupivacaine with dexamethasone 4mg (1 ml)
COMPARATOR AGENT: 0.5% Levobupivacaine with 1 ml normal saline
55
RANDOMISATION, ALLOCATION CONCEALMENT AND BLINDING:
The patients who were recruited for the study were randomised into two arms. One
group got 30ml 0.5% Levobupivacaine plus four milligrams of dexamethasone 1ml
and the other group 30ml 0.5% Levobupivacaine with 1 ml normal saline. The
randomisation sequence was generated by a biostatistician not directly involved in the
study using a computer programme. The randomization sequence was handed over to
the pharmacist who packaged and labelled the drugs.
The drugs manufactured by the Neon Labs, were packaged in amber colored bottles
by the department of Pharmacy, Christian Medical College, Vellore. These bottles
were then carefully organized as per the randomization sequence and were labelled
from 1 to 60. The drugs were then handed over to the principal investigator to be used
in patients in a sequential order. Block randomization method was used. The patient
and the principal investigator remained blinded about the drug being administered
throughout the period of study. The randomization code was confidentially preserved
in the department of pharmacy till it was unblinded at the end of the study.
Study was done among the patients who underwent forearm orthopaedic surgeries in
Christian Medical College, Vellore, May to August 2016. A total of 40 patients ASA
(American Society of Anaesthesiologist) preoperative risk classification I, II and III
aged between18 to 70 were included in the study.
56
INCLUSION CRITERIA:
1. Age between 18-70yrs posted for forearm surgery
2. ASA I-III
3. Patients who are willing to undergo the block.
4. Weight greater than or equal to 50kg
EXCLUSION CRITERIA:
Patients who are not willing for the block
Patient’s with coagulopathy
Local infection over the block area
Pregnant women
Patients requiring general anaesthesia
Patient’s weighing less than 50kg.
Allergy to local anesthetic
CONSENT:
The information sheet containing all relevant information in lay language translated
into the language patient or patient’s relative can understand was provided sufficiently
prior to the surgery for them to deliberate and clarify. The principal investigator
discussed about the study with the patient and clarified their queries on the night
before the surgery. Then the patient was invited to be a part of the study and the
57
consent signature was obtained in the consent form. Patients were recruited and given
a study number after informed written consent.
IMPLEMENTATION:
The consenting patients who fulfilled the inclusion criteria were recruited into the
study.
The patients were premedicated with Tab. Diazepam 5mg and Cap. Omeprazole 20
mg on the day of the surgery and standard preoperative fasting orders were followed.
In the operating room an intravenous access was obtained in the opposite side of the
limb undergoing surgery and block performed with standard monitoring such as ECG,
pulse oxymetry and blood pressure. This is as per ASA (American Society of
Anaesthesiologists) guidelines. In each group under aseptic precautions brachial
plexus block was performed via the infraclavicular approach using SonoSite S nerve
ultrasound system using a 13-6 MHZ linear frequency probe and an 22g Sonoplex
nano Lins stim canula. We identified the 2nd part of the axillary artery and vein using
ultrasound and given 1-2ml of local infiltration to the skin and using the sonoplex
nanolins stim canula confirmed the cords by using the nerve stimulator once the
twitches are identified till 0.5 m Amp current then 30 ml of the drug is administered
along the 3 regions surrounding the 2 nd part of axillary artery to cover posterior
medial and lateral cords.
58
.
Figure 4.1: Ultrasound machine S Nerve used in our study
59
Figure 4.2: High frequency linear probe 13-6 MHZ used in the study
Figure 4.3: Sonoplex needle used in the study
60
Figure 4.4: Ultrasound image showing needle advancement around the posterior cord
Figure 4.5: Ultrasound image showing needle advancement around the lateral cord
61
Figure 4.6: Ultrasound image showing needle advancement around the medial cord
Initial assessment was immediately after administration of the drug till 20 minutes.
Patients were assessed for sensory blockade by pin prick using a 26G needle or Ice
cube in the dermatomal distribution of ulnar, median and radial nerves. Sensation over
the thenar eminence is median, dorsum of hand is radial and hypothenar corresponds
to ulnar and graded accordingly as Grade 0- pain/normal sensation ,Grade 1-analgesia
/ decreased sensation, Grade 2-anesthesia / no sensation. A modified Bromage scale
for the upper extremity was used to assess motor power and was assessed by the
primary investigator. This scale consists of the following 4 scores: 0, able to raise the
extended arm to 90° for a full 2 seconds; 1, able to flex the elbow and move the
fingers but unable to raise the extended arm;2, unable to flex the elbow but able to
move the fingers; and 3, unable to move the arm, elbow, or fingers. End of the
injection of the drug was taken as time 0. Patients were evaluated for the onset of
62
sensory every 1,2,3,4,5,10,15,20 minutes and motor blockade every 5, 10, 15, 20
minutes and duration of analgesia postoperatively at 3 hours, 6 hours and 12 hours for
24 hours. Patients were assessed for sensory blockade by pin prick using a 26G needle
in the dermatomal distribution of ulnar, median and radial nerves.
A modified Bromage scale for the upper extremity was used to assess motor power
and was assessed by the primary investigator. Postoperatively, perception of pain was
assessed using the visual analog scale (VAS). The staff nurse assigned to the patient
documented the visual analog scale under the supervision of the primary investigator.
Rescue analgesia was administered when VAS score was equal to or more than 4.
Rescue analgesia was Tab. Aceclofenac. This was followed by 0.1 mg/kg morphine if
pain score remains more than 4 despite administration of Aceclofenac. Number of
rescue medications between the two groups was noted.
PRIMARY OUTCOME:
To compare the onset of sensory and motor blockade of 0.5% Levobupivacaine with
dexamethasone versus 0.5% Levobupivacaine with 1 ml normal saline.
SECONDARY OUTCOME:
To compare the duration of postoperative analgesia and requirement for rescue
analgesia between the two groups (0.5% Levobupivacaine with dexamethasone versus
0.5% Levobupivacaine with 1 ml normal saline).
63
SUMMARY OF METHODOLOGY
Figure: 4.7: Flow chart of the study
64
SAMPLE SIZE CALCULATION:
Target sample size and rationale:
To estimate the mean difference of 3 minutes in onset of sensory block between two
groups with standard deviation of 4 and 80% power at 5% level of significance, the
required sample size was estimated to be 60 (30 in each group).
Formula:
N= 2σ2 [Z1-α/2+Z1-β]2 /[μ1-μ2]2
Mean difference, μ1-μ2 = 3 mins
Standard deviation, σ = 4 mins
Normal value of Z1-α/2 for 5% level of significance= 1.96
Normal value of Z1-β for 80% power = 0.84
N= 2*42[1.96+0.84]2/[3]2 = 28 ∼ 30
Descriptive statistics for all continuous variables was given using Mean (SD) or
Median (IQR). Categorical factors were presented using frequency and percentage
and their association with the two groups were assessed using chi-square test. The
primary outcome and all other continuous covariates were assessed for normality
assumption and independent t-test was used.
To assess the association between two groups else Mann-Whitney U test was used.
The correlation of primary outcome with all other continuous covariates was assessed
65
using Pearson correlation coefficient or Spearman’s rank correlation. P-value of <0.05
was considered for statistical significance.
STATISTICAL ANALYSIS
Data was summarized using mean (SD)/ median (IQR) for continuous variables and
frequency (percentage) for categorical variables. Independent test/rank sum test
(continuous) and chi-square (categorical) tests were used to compare the baseline
characteristics among the drugs. The outcome was defined as grade improvement
from 3min to 20min. A chi-square test was performed to compare the improvement
among drugs. A fisher exact test was used to compare the 3 min and 20 min grading
among the drug groups. All the significance levels were kept for p<0.05. All the
statistical analysis was done using stataic 13.1.
66
5. RESULTS
The data collected have been analysed under the following categories
I. Description of baseline characteristics
II. Data obtained during the intra operative period
III. Data obtained in the post-operative period
DESCRIPTION OF BASELINE CHARACTERISTICS
Baseline characteristics of the patients have been enumerated in Table no 1. On the
whole there were no significant differences in the baseline characteristics of both
treatment arms. In this study we assessed 45 patients for eligibility to be included in
the study. 5 patients were excluded as some of them did not fulfil the inclusion criteria
and for some others there was a change in the operative plan on the day of surgery.
Hence a total of 40 patients were recruited with ASA (American Society of
Anaesthesiologist) preoperative risk classification I, II and III. The patients were aged
between 18 to 70 years. Data collected from 40 patients was analysed with 20 patients
in one arm and 20 patients in another arm.
67
Table 5.2 General demographic characteristics of study participants in relation to
drug
Variable Levobupivacaine
with
dexamethasone
Levobupivacaine Total
(n=40)
P value
Age
group
18-35
years
12 12 24
0.81 36-55
years
06 06 12
56-75
years
02 02 04
Figure 5.1 Range of age in both groups
68
Table 5.2: Association of variables with drug
Variables
Levobupivacaine
with
dexamethasone
(n=20)
Levobupivacaine
(n=20)
P value
Age Mean, (SD) 34.90 (14.48) 35.90 (12.85) 0.77
Height Mean, (SD) 167.35 (7.01) 163.55 ( 8.73) 0.54
Weight Mean, (SD) 68.85 (14.77) 65.60 (8.98) 0.37
BMI Mean, (SD) 24.58(4.98) 24.54(2.91) 0.98
AGE AND GENDER:
The mean age of the participants in the study was around 36 years, the youngest being
18 years and the oldest 65 years. Of the 40 patients analysed, 37 were male and 3 were
female.
The mean BMI of the participants in the study was around 25 kg/m2, minimum is 17
kg/m2 and maximum being 35 kg/m2.
ASA PHYSICAL STATUS CLASSIFICATION:
Majority of the patients (28 out of the 40) recruited in the study were of ASA
Physical status grade 1.(Table 2)
69
Table 5.3: American Society of anaesthesiologists grading of physical status
classification in study population
ASA grading Total (n=40)
Grade 1 28 (70.00%)
Grade 2 10 (25.00%)
Grade 3 2 (5.00%)
Table 5.4: Association of ASA grading and drug:
ASA
physical
Status
Levobupivacaine
with
dexamethasone
n(%)
Levobupivacaine
n(%)
Total
n(%)
P value(chi2)
Grade 1 12(60.00%) 16(80.00%) 28(70.00%) 0.226(2.9714)
Grade 2 6 (30.00%) 4 (20.00%) 10(25.0%)
Grade 3 2 (10%) 0(0.00%) 2(5.00%)
Figure 5.2 American Society of Anaesthesiologists Grading Of Physical Status
Classification In Study Population
70
Table 5.5: Frequency Distribution of the Drug
Drug Total (n=40)
LEVOBUPIVACAINE AND
DEXAMETHASONE
20( 50.00%)
LEVOBUPIVACAINE 20 (50.00%%)
There was equal distrubution of patients in both arms (50%)
Figure 5.3 Distribution of the study population between both the groups
DURATION OF SURGERY:
Duration of surgery in both the Levobupivacaine with dexamethasone and
Levobupivacaine arms was comparable around 1 hour 20 minutes to 1 hr 40 min.
71
Table 5.6 Comparison of Duration of Surgery in Both Groups
LEVOBUPIVACAINE WITH
DEXAMETHASONE
LEVOBUPIVACAINE P VALUE
DURATION
OF
SURGERY
MEAN SD MEAN SD 0.145
80.25 38.51 104.45 61.73
Figure 5.4 Comparison of duration of surgery in both groups
72
Table 5.7 Comparison of Means and standard deviations (SD) of baseline
characteristics
Variables
Levobupivacaine
with
dexamethasone
(n=20)
Levobupivacaine
(n=20)
P value
Age Mean, (SD) 34.90 (14.48) 35.90 (12.85) 0.818
Height Mean, (SD) 167.35 (7.01) 163.55 ( 8.73) 0.14
Weight Mean, (SD) 68.85 (14.77) 65.60 (8.98) 0.41
BMI Mean, (SD) 24.58(4.98) 24.54(2.91) 0.98
Dur.ofsurgery Mean,
(SD)
80.25(38.51) 99.50 (65.93) 0.15
Systolic BP Mean, (SD) 133.35(15.48) 125.40 (11.93) 0.07
Diastolic BP Mean, (SD) 73.75 (7.97) 76.50 (7.74) 0.27
Sp02 Mean, (SD) 99.70 (0.80) 99.75 (0.91) 0.85
Heart rate Mean, (SD) 77.70 (13.16) 112.35 (150.51) 0.86
PPT systolic BP Mean,
(SD)
125.45 (14.36) 120.65 (14.08) 0.29
PPT diastolic BP Mean,
(SD)
71.90(7.53) 71.95 (8.17) 0.98
PPT Spo2 Mean, (SD) 99.55 (1.10) 99.90 (0.45) 0.19
PPT heart rate Mean,
(SD)
77.45(11.48) 75.35 (10.38) 0.55
73
Table 5.8 Frequency Distribution Of The Midazolam
Midazolam Total (n=40)
Given 28 (70.00%)
Not given 12 (30.00%)
Among the 40 study participants, midazolam was given to 70% of patients .
Figure 5.5 Frequency Distribution Of The Midazolam
Table 5.9 Frequency Distribution Of The Fentanyl Administered
Fentanyl Total (n=40)
Given 28 (70.00%)
Not given 12 (30.00%)
Among the study population fentanyl was given to 70% of patients.
74
Figure 5.6 Frequency Distribution Of The Fentanyl
DATA OBTAINED DURING THE INTRA OPERATIVE PERIOD
Table 5.10 SENSORY GRADING OF RADIAL NERVE
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 2
(anesthesia/
no sensation)
Radial nerve 1 min 20 (52.63%) 15 (39.47%) 3 (7.89%)
2 min 16 (42.11%) 19 (50.00%) 3 (7.89%)
3 min 14 (36.84%) 21 (55.26%) 3 (7.89%)
4 min 10 (25.64%) 24 (61.54%) 5 (12.82%)
5 min 4 (10.00%) 27 (67.50%) 9 (22.50%)
10 min 2 (5.00%) 22 (55.00%) 16 (40.00%)
15 min 2 (5.00%) 14 (35.00%) 24 (60.00%)
20 min 2 (2.56%) 6 (15.00%) 32 (80.00%)
75
Table 5.11: Improvement Of Radial Nerve And Drug Association
Improvement of Radial
nerve sensory grading
Levobupivacaine
with dexamethasone
Levobupivacaine P value(chi2)
0 3(5.00%) 7(35.00%) 0.144(2.133)
1 17(85.00%) 13(65.00%)
Total 20(100%) 20(100%)
There was considerable improvement of sensory grading from 5 to 85 % in
Levobupivacaine with dexamethasone group and also the difference between two
groups was 20% for grade 1 sensory grading of radial nerve. Over all P value was
0.144 which shows no significant improvement in radial nerve sensory grading
between the time duration of 3 min to 20 min.
76
Table 5.12 Association For Onset Of Anaesthesia And Drug In Radial Nerve
LEVOBUPIVACAINE WITH
DEXAMETHASONE
LEVOBUPIVACAINE
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia
/
decreased
sensation)
Grade 2
(anesthesia
/ no
sensation)
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 2
(anesthesia/
no
sensation)
Radial
Nerve
1
min
12
(63.16%)
6 (31.58%) 1 (5.26%) 8 (42.11%) 9 (47.37%) 2 (10.53%)
2
min
11
(57.89%)
7 (36.84%) 1 (5.26%) 5 (26.32%) 12 (63.16%) 2 (10.53%)
3
min
10
(52.63%)
8 (42.11%) 1 (5.26%) 4 (21.05%) 13 (68.42%) 2 (10.53%)
4
min
7
(35.00%)
12
(60.00%)
1 (5.00%) 3 (15.79%) 12 (63.16%) 4 (21.05%)
5
min
2
(10.00%)
15
(75.00%)
3 (15.00%) 2 (10.00%) 12 (60.00%) 6 (30.00%)
10
min
1 (5.00%) 13
(65.00%)
6 (30.00%) 1(5.00%) 9 (45.00%) 10 (50.00%)
77
15
min
1 (5.00%) 7 (35.00%) 12
(60.00%)
1 (5.00%) 7 (35.00%) 12 (60.00%)
20
min
1 (5.00%) 2 (10.00%) 17
(85.00%)
1 (5.00%) 4 (20.00%) 15 (75.00%)
In Levobupivacaine with dexamethasone group, 60-75% of the patients had onset of
sensory blockade for radial nerve around 4-5 min and 85% at the end of 20 min where
as 75% achieved sensory blockade of radial nerve after 20 min in Levobupivacaine
group. However this was not statistically significant.
Table 5.13 Association For Onset Of Anaesthesia And Drug In Median Nerve
Grade 0 (pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 2
(anesthesia/ no
sensation)
Median nerve 1 min 21 (52.50%) 16 (40.00%) 3 (7.50%)
2 min 17 (42.50%) 20 (50.00%) 3 (7.50%)
3 min 13 (32.50%) 23 (57.50%) 4 (10.00%)
4 min 10 (25.00%) 23 (60.00%) 6 (15.00%)
5 min 3 (7.50%) 28 (72.50%) 8 (20.00%)
10 min 2 (5.00%) 24(60.00%) 14 (35.00%)
15 min 2 (5.00%) 17 (42.50%) 21 (52.50%)
20 min 1 (2.50%) 11(27.50%) 28 (70.00%)
Around 60-70% of the patients had onset of anaesthesia by around 4-5 minutes and
70% had anaesthesia by 20 minutes in median nerve
78
Table 5.14: Improvement Of Median Nerve And Drug Association
Improvement of
sensory blockade
in medial nerve
Levobupivacaine
with
deamethasone
Levobupivaciane P(chi2)
Grade 0 2(10%) 8(40%) 0.028
Grade 1 18(90%) 12(60%)
20(100%) 20(100%)
There was a considerable improvement in sensory grading from 10 to 90 % in
levobupivacaine with dexamethasone group and also the difference between the two
groups was 30% for grade 1. P value was 0.028.This shows statistically significant
improvement in median nerve sensory grading between a duration of 3 min and 20
min.
79
Table 5.15 Association Between Onset Of Sensory Blockade And The Drug For
Median Nerve
Levobupivacaine with
dexamethasone
Levobupivacaine
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia
/ decreased
sensation)
Grade 2
(anesthesia
/ no
sensation)
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 2
(anesthesia/
no
sensation)
Median
Nerve
1
min
11
(55.00%)
8(40.00%) 1 (5.00%) 10
(50.00%)
8 (40.00%) 2 (10.00%)
2
min
10
(50.00%)
9 (45.00%) 1 (5.00%) 7(35.00%) 11 (55.00%) 2 (10.00%)
3
min
8
(40.00%)
11
(55.00%)
1 (5.00%) 5 (25.00%) 12 (60.00%) 3 (15.00%)
4
min
5
(25.00%)
14
(70.00%)
1 (5.00%) 5 (25.00%) 10 (50.00%) 5 (25.00%)
5
min
2
(10.00%)
15
(75.00%)
3 (15.00%) 1 (5.00%) 14 (70.00%) 5 (25.00%)
10
min
1
(05.26%)
13
(65.00%)
6 (30.00%) 1(5.00%) 11 (55.00%) 08 (40.00%)
80
15
min
1 (5.00%) 7 (35.00%) 10
(60.00%)
1 (5.00%) 10 (50.00%) 09 (45.00%)
20
min
0 (0.0%) 4 (20.00%) 16
(80.00%)
1 (5.00%) 7 (35.00%) 12 (60.00%)
In levobupivacaine with dexamethasone group, 70-75% of the patients had onset of
sensory blockade for median nerve around 4-5 min and 85% at the end of 20 min
where as 60% achieved complete sensory blockade for median nerve after 20 min in
levobupivacaine group.
Table 5.16 Association Between Onset Of Sensory Blockade And The Drug For Ulnar
Nerve
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 2
(anesthesia/
no sensation)
Ulnar nerve 1 min 21 (52.50%) 18 (45.00%) 1 (2.50%)
2 min 17(42.50%) 20 (52.50%) 2 (5.00%)
3 min 10 (25.00%) 25 (65.00%) 4 (10.00%)
4 min 6 (15.00%) 27 (67.50%) 7 (17.50%)
5 min 2 (5.00%) 29 (72.50%) 9 (22.50%)
10 min 1 (2.50%) 22 (57.50%) 16 (40.00%)
15 min 2 (5.00%) 14 (35.00%) 24 (60.00%)
20 min 2 (5.00%) 9 (22.50%) 29 (72.50%)
81
Around 65-70% of the patients had onset of anaesthesia by around 4-5 minutes .
Almost 70% had complete sensory anaesthesia by 20 minutes in ulnar nerve.
Table 5.17: Improvement Of Ulnar Nerve And Drug Association
Improvement of
sensory blockade
in ulnar nerve
Levobupivacaine
with
dexamethasone
Levobupivacaine P value(chi2)
0 2(10.00%) 9(45.00%) 0.013(6.1442)
1 18(90.00%) 11(55.00%)
20(100.00%) 20(100.00%)
There was a significant improvement of sensory grading from 10 to 90% in
levobupivacaine with dexamethasone group and also the difference between the two
groups was 45% for grade 1. P value was 0.013 which shows a significant
improvement in ulnar nerve between duration of 3 min and 20 min.
82
Table 5.18: Association Between Onset Of Sensory Blockade And The Drug For
Ulnar Nerve
LEVOBUPIVACAINE WITH
DEXAMETHASONE
LEVOBUPIVACAINE
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia
/
decreased
sensation)
Grade 1
(analgesia
/
decreased
sensation)
Grade 0
(pain/
normal
sensation)
Grade 1
(analgesia /
decreased
sensation)
Grade 1
(analgesia /
decreased
sensation)
Ulnar
Nerve
1
min
12
(60.00%)
8( 40.00%) 0(0.00 %) 9(45.00 %) 10(50.00 %) 1(05.00%)
2
min
10(50.00
%)
10(50.00
%)
0(0.00 %) 7(35.00 %) 11(55.00%) 2(10.00%)
3
min
06(30.00
%)
13(65.00%
)
1(5.00%) 4(20.00 %) 13(65.00 %) 3(15.00%)
4
min
03(15.00
%)
14(70.00
%)
3( 15.00%) 3(15.00 %) 13(65.00 %) 4(20.00%)
5
min
01(5.00%) 15(75.00%
)
4( 20.00%) 1( 5.00 %) 14(70.00 %) 5(25.00%)
83
10
min
0(0.00 %) 11(55.00%
)
9(45.00%) 1(5.00 %) 12(60.00%) 7(35.00%)
15
min
1(5.00 %) 6(30.00%) 13(65.00%
)
1(5.00%) 8(40.00%) 11(55.00 %)
20
min
0(5.00 %) 2(10.00%) 17(85.00%
)
1( 5.00%) 7(35.00%) 12(60.00%)
In levobupivacaine with dexamethasone group, 70-75% of the patients had onset of
anaesthesia around 4-5 min and 85% at the end of 20 min where as 60% achieved
complete sensory blockade after 20 min in levobupivacaine group for ulnar nerve.
Table 5.19: Duration And Motor Grading Using Modified Bromage Scale
Motor
grading
Grade
0
Grade 1 Grade 2 Grade 3
0 0 1 0 2 0 3
T
i
m
e
5
min
9 2
(13.33%)
13
(86.67%)
2
(25.00%)
6
(75.00%)
1 (50.00%) 1 (50.0%)
10
min
4 1 (5.26%) 18
(94.74%)
2
(12.50%)
13
(87.50%)
1 (50.00%) 1 (50.0%)
15
min
2 1 (7.14%) 13
(92.86%)
2 (8.33%) 21
(91.67%)
1 (33.33%) 1 (66.67%)
20
min
2 1
(33.33%)
2
(66.67%)
1 (3.57%) 25
(96.43%)
1
(16.67%)
5 (83.33%)
Almost 80% of patients had onset of motor blockade at 10 min
62.5% of the population had grade 2 motor blockade.
84
Table 5.20: Motor Grade Improvement And Drug Association At 5 Min
Grade of motor
improvement at
5 min
Levobupivacaine
with
dexamethasone
Levobupivacaine Fischer exact
0 5(33.33%) 4(28.57%) 0.262
1 5(33.33%) 8(57.14%)
2 5(33.33%) 1(7.14%)
3 0(0.00%) 1(7.14%)
There is no statistical significant improvement in motor grading at the end of 5 min
85
Table 5.21: Motor grade improvement and drug association at 20 min
Grade of motor
improvement at
20 min
Levobupivacaine
with dexamethasone
levobupivacaine Fischer exact
0 1(5.88%) 1(5.56%) 0.025
1 0(0.00%) 2(11.11%)
2 11(64.71%) 15(83.35%)
3 5(29.41%) 0(0.00%)
Motor improvement at end of 20 min is statistically significant. There is an 65 %
improvement of grade 1 to grade 2 in Levobupivaicane with dexamethasone group
and 85% improvement with Levobupivaciane group.
86
Table 5.22: Modified Bromge Scale Grading In Association With Drug
Levobupivacaine with dexamethasone
Motor grading
Levobupivacaine
Motor grading
Time Grade 0 Grade
1
Grade
2
Grade
3
Grade
0
Grade
1
Grade
2
Grade
3
5min 5
6 5 0 4 9 2 2
10min 2 9 8 0 2 10 7 2
15min 1 6 12 3 2 8 11 1
20min 1 0 11 6 1 3 16 1
87
Table 5.23: Adequacy Of Surgical Anesthesia
Adequacy of surgical anasthesia Total (n=40)
Yes 35 (87.50%)
No 5 (12.50%)
Figure 5. 7: Adequacy Of Surgical Anaesthesia
88
Table 5.24: Association Between Adequacy Of Surgical Anaesthesia And Drug Used
Drug Total Chi
square
P value
1 2
Yes 18
(90.00%)
17
(85.00%)
35 (87.50%) 0.2286 0.633
No 2(10.00%) 3
(15.00%)
5 (12.50%)
The adequacy of surgical anaesthesia was assumed to be satisfactory when the
surgeon was able to perform the surgery with complete sensory and motor blockade of
the patient’s forearm and when the patient was completely painless during the surgery.
Among the 40 patients who underwent forearm orthopaedic surgeries infraclavicular
block was able to provide adequate surgical anaesthesia for 87.5% of patients. In both
the groups the success of the block is negligible as p value is 0.633.
DATA OBTAINED IN THE POST-OPERATIVE PERIOD
Post operative analgesia requirement was measured using an visual analog scale
(VAS) . In this study the highest score was 7.
Table 5.25 VAS SCORE
VAS score 0 1 2 3 7
Time in
hours
3 hours 28
(70.00%)
8
(20.00%)
4
(10.00%)
6 hours 24
(60.00%)
11
(27.50%)
4
(10.00%)
1
(2.50%)
12 hours 22(55.00%) 11
(27.50%)
4
(10.00%)
2
(5.00%)
1
(2.50%)
24 hours 21
(52.50%)
7
(17.50%)
11
(27.50%)
1
(2.50%)
89
Table 5.26: VAS score in relation to Levobupivacaine and Dexamethasone
Levobupivacaine with dexamethasone
VAS
score
0 1 2 3 7
Time in
hours
3hrs 13(65.00%) 5(25.00%) 2(10.00%)
6hrs 11(55.00%) 8(40.00%) 1(5.00%)
12hrs 11(55.00%) 6(30.00%) 2(10.00%) 1(5.00%)
24hrs 10(50.00%) 5(25.00%) 5(25.00%)
Table 5.27: VAS score in relation to Levobupivacaine
Levobupivacaine
VAS
score
0 1 2 3 7
Time
in
hours
3hrs 15(75.00%) 3(15.00%) 10
6hrs 13(65.00%) 3(15.00%) 3(15.00%) 1(5.00%)
12hrs 11(55.00%) 5(25.00%) 2(10.00%) 1(5.00%) 1(5.00%)
24hrs 11(55.00%) 2(10.00%) 6(30.00%) 1(5.00%)
Post-operative pain was measured using an visual analog scale ranging from 0-10 and
was recorded at various time intervals. There were no differences in post-operative
pain scores in both arms.
In Levobupivacaine with dexamethasone group the maximum documented pain score
was 3 where as in the Levobupivacaine group it is 3 and 7. However it was
statistically insignificant.
90
Table 5.28: Supplementation of Aceclofenac in study population
12 hrs 24 hrs
T.Aceclofenac Given 4 (10.00%) 3 (7.50%)
Not
given
36(90.00%) 35
(92.50%)
In the entire study population only 4 needed tab. Aceclofenac after 12 hrs where as the
rest never needed.
Table 5.29: Aceclofenac administration in relation to drug
Time of
administration
of Aceclofenac
Levobupivacaine
with dexamethasone
Levobupivacaine
12 hrs 1(5.26%) 3(15.79%)
24 hrs 1(5.26%) 2(10.53%)
In both groups Aceclofenac administration was minimal.
Table 5.30: Supplementation of Morphine in study population.
6 hrs 12 hrs 18 hrs 24 hrs
Inj.
Morphine
0.1 mg/kg
Given 0 1 (2.50%) 0 0
Not
given
39 38
(97.50%)
39 39
Table 5.31 Association of Morphine and drug.
6hrs 12hrs 18hrs 24hrs P value
Levobupivacaine
with
dexamethasone
given 0 0 0 0
Not
given
20 20 20 20
Levobupivacaine given 0 1(5.00%) 0 0
Not
given
19 19 19 19
91
In the post operative period only 1 participant in the Levobupivacaine arm had 1 dose
of morphine and there is no statistical significance between two arms in relation to
administration of morphine.
Table 5.32: Supplementation of Paracetamol in study population
6 hrs 12 hrs 18 hrs 24 hrs
Inj.
Paracetamol
Given 1 (2.56%) 5
(12.50%)
3(7.89%) 3(7.69%)
Not
given
39
(94.44%)
35
(87.50%)
37(92.11%) 37(92.31%)
Table 5.33: Association Of Paracetamol And Drug
6hrs 12hrs 18hrs 24hrs
Levobupivacaine
with
dexamethasone
Given 0 2 1 1
Not
given
20 18 19 19
Levobupivacaine Given 1 3 2 1
Not
given
19 17 18 20
92
6. DISCUSSION
In orthopedic surgeries involving the forearm, surgical anesthesia can be achieved by
regional anesthesia techniques which frequently involve a brachial plexus block.
Regional anaesthesia is an excellent alternative to general anaesthesia specially for
surgeries involving extremity (12). This technique provides longer duration of pain
relief, minimizes intra and post operative requirements of opiods while at the same
time avoiding the complications of general anesthesia which include airway trauma,
postoperative nausea and vomiting. Lower arm anesthesia, from the elbow to the
hand, may be promptly achieved by injection of local anaesthetic around the brachial
plexus(13). It provides better analgesia in the post operative period and quicker
recovery from the anaesthesia. During the early postoperative phase of healing,
sometimes post operative analgesic duration is not adequate to compensate acute
nociception associated with surgery. In an effort to enhance post operative analgesia,
many adjuvants like clonidine, buprenorphine, neostigmine, tramadol,epinephrine and
dexamethasone have been added to local anesthetics (LA)(12,14). Several clinical
studies have assessed the efficacy of dexamethasone applied perineurally with local
anaesthetics in regional nerve blocks including epidural(15,16) brachial plexus (17),
femoral and sciatic(18) and facial and dental blocks (19). Alternatives used for
checking postoperative pain (e.g., duration of analgesia, pain scores, opioid
consumption) appear to be enhanced by the addition of dexamethasone to LA agents
injected perineurally (20).
93
Innervation of the arm comes from different nerves. Hence the extent of blockade is
best assessed by evaluating functions unique to each terminal nerve. Pain scores were
lowered at 24 hours and 48 hours postoperatively by adding dexamethasone to local
anaesthetic, corresponding to less opioid consumption over those 24– 48 hours. This
opioid-sparing effect could potentially translate into a reduction in opioid-related
adverse events, including nausea, vomiting, pruritis, and urinary retention,
constipation, and respiratory depression(12). Perineurally administered
dexamethasone added to local anaesthetic delayed the latency and prolonged the
recovery of motor block after brachial plexus block, similar to the analysis from Choi
et al (21). According to a study done by Jasminka, single-shot dexamethasone in a
mixture with Levobupivacaine for Supraclavicular block results in prolonged
analgesia duration and less analgesic use in comparison with Levobupivacaine(106).
Dexamethasone is a highly potent, long-acting glucocorticoid with little
mineralocorticoid effect. It has shown to prolong peripheral nerve blockade in
animals. When dexamethasone is added to bupivacaine microspheres, it extends the
duration of analgesia in humans(8,10).
In our study we found that there was considerable improvement of sensory grading
from 5 to 85 % in levobupivacaine with dexamethasone group and also the difference
between two groups was 20% for grade 1 sensory grading of radial nerve. Over all P
value was 0.144 which shows no significant improvement in radial nerve sensory
grading between the time duration of 3 min to 20 min.(Table 7)
In Levobupivacaine with dexamethasone group, 60-75% of the patients had onset of
sensory blockade for radial nerve around 4-5 min and 85% at the end of 20 min where
94
as 75% achieved sensory blockade of radial nerve after 20 min in Levobupivacaine
group. However this was not statistically significant.(Table 8)
There was a considerable improvement in sensory grading from 10 to 90 % in
Levobupivacaine with dexamethasone group and also the difference between the two
groups was 30% for grade 1. P value was 0.028.This shows statistically significant
improvement in median nerve sensory grading between a duration of 3 min and 20
min.(Table 9)
There was a significant improvement of sensory grading from 10 to 90% in
Levobupivacaine with dexamethasone group and also the difference between the two
groups was 45% for grade 1. P value was 0.013 which shows a significant
improvement in ulnar nerve between duration of 3 min and 20 min.(Table 11)
In our study almost 80% of the patients had onset of motor blockade at the end of 10
min. The difference between the two groups is although not significant.
In our study we identified 65% improvement in motor grading to grade 2 in
Levobupivacane with dexamthasone and 85% improvement to grade 2 in
levobupivacaine at the end of 20 min overall there is significant improvement of
motor blockade at the end of 20 min p value is 0.025 .
Infraclavicular block in particular has its advantages over supraclavicular block. It has
fewer complications, provides complete surgical anesthesia of the operative part, and
immobilization of the upper limb during surgery. The purported advantages of
infraclavicular block are as follows. First, it provides complete anaesthesia of the
upper limb as it blocks the brachial plexus where the three cords run close together in
95
a neurovascular bundle with the axillary artery. There also appears to be a lower
incidence of tourniquet pain with the infraclavicular block, which is attributed to
spread to the intercostobrachial nerve that runs close to the brachial plexus in the
infraclavicular space(48,49). Secondly, the risk of inadvertent lung or pleural puncture
is lower than with the interscalene and supraclavicular approaches as the lung does not
lie in the path of the needle. Thirdly, by piercing the skin below the clavicle, injury to
the other neurovascular structures in the neck are avoided (unlike with the interscalene
or supraclavicular approaches). Fourthly, infraclavicular block does not require
abduction of the arm at the shoulder and can be performed in any arm position and the
neck position need not be changed(50). In our study, patients were assessed for
sensory blockade by pin prick using a 26G needle or ice cube in the dermatomal
distribution of ulnar, median and radial nerves. A modified Bromage scale for the
upper extremity was used to assess motor power.
In our study, among the 40 patients who underwent forearm orthopaedic surgeries,
infraclavicular block was able to provide adequate surgical anesthesia for 87.5% of
patients. But the success of the block was not statistically significant. P value was
0.33.(Table 14)
In our study, post-operative pain was measured using an visual analog scale ranging
from 0-10 and was recorded at various time intervals. There were no differences in
post-operative pain scores in both arms.(Table 15). Only 5% of patients in
Levobupivacaine with dexamethasone group required aceclofenac at the end of 2
hours compared to 15% of patients in Levobupivacaine.
96
The technique of brachial plexus block may result in neurological complications
including respiratory distress, Horner’s syndrome and recurrent laryngeal nerve
injury(22). However, none of the patients developed any complication directly
attributable to the intervention. There was no incidence of post-operative nausea and
vomiting in any of the patients.
97
7. CONCLUSION
1. There was no statistical difference in the onset of sensory and motor blockade of
0.5% Levobupivacaine with 4mg of dexamethasone and 0.5% Levobupivacaine with
1 ml of normal saline added in infraclavicular block in patients undergoing forearm
orthopaedic surgeries . However there was a significant improvement in sensory
grading of median nerve and ulnar nerve between a duration of 3 min and 20 min.(P
value was 0.028 and 0.013 respectively) and also in motor grading improvement at 20
min duration (P value 0.025) in the group with 0.5% Levobupivacaine with 4mg of
dexamethasone in comparison with the group with 0.5% Levobupivacaine with 1 ml
of normal saline.
2. There was no difference in the duration of post-operative analgesia in the group
with 0.5% Levobupivacaine with dexamethasone when compared with the group with
0.5% Levobupivacaine with 1 ml of normal saline added in infraclavicular block in
patients undergoing forearm orthopaedic surgeries.
98
8. LIMITATIONS
Although a larger sample size might have brought out some difference in the post-
operative pain scores in favour of addition of dexamethasone, its clinical implication
is doubtful.
99
9. Scope For Future Research:
A study with larger population size with higher frequency probes can be used to apply
the results in a larger population.
100
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Annexure 1: Institutional review board acceptance and fluid grant
letter
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113
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Annexure 2: Information sheet
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Annexure 3:Informed consent form
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Annexure 4: Informed consent in Hindi
117
Annexure 5: Patient information sheet in Hindi
118
119
Annexure 7: Informed consent form in Tamil
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Annexure 8: PROFORMA of the study
Levobupivacaine with dexamethasone versus levobupivicaine in patients undergoing
forearm and hand surgeries under an infraclavicular block
1.Study no:
2.Name:
3.Hospital number :
4.Mobile number :
5.Age ( in years)
6.Height : Weight:
7.Name of surgery:
8.Date of surgery:
9.DRUG: A /B
10.Duration of surgery:
ASA grade:
Preoperative:
Baseline vitals : BP, SPO2,HR-
Midazolam:
Fentanyl:
11.Time of Onset of sensory blockade:
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Nerves
Grading
1min 2min 3min 4min 5min 10
min
15
min
20min
Radial
nerve
Median
nerve
Ulnar
nerve
Grading of sensory blockade pin prick/ice. Thenar eminence- median , dorsum of
hand –radial
Hypothenar –ulnar .
Grade 0- pain / normal sensation .
Grade 1-analgesia / decreased sensation
Grade 2-anesthesia / no sensation
12. Onset of Motor blockade:
Grading 5 min 10 min 15min 20 min
0
1
2
3
This scale ( modified bromage )consists of the following 4 scores:
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0- able to raise the extended arm to 90°for a full 2 seconds;
1 -able to flex the elbow and move the fingers but unableto raise the extended arm;
2 -unable to flex the elbow but able to move the fingers; and
3 -unable to move the arm, elbow, or fingers
Intraop analgesia:
POST PROCEDURE VITALS:BP,SPO2,HR-
Intraoperative: ADEQUECY OF SURGICAL ANESTHESIA
YES
NO
If no, please mention if additional analgesics were given or if conversion to general
anaesthesia was
needed
Post operative:
12.Duration of analgesia
Time 3hrs 6hrs 12hrs 24hrs
VAS
Tab
aceclofenac
Inj morphine
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13. VAS score: 0/1/2/3/4/5/6/7/8/9/10
14. Tab Aceclofenac: Yes/No
15. inj .Morphine 0.1mg/kg: yes/no
16.inj .paracetmol 1gm :yes /no.