COMPARATIVE EVALUATION OF

ULTRASOUND GUIDED SUPRA INGUINAL

VERSUS INFRA INGUINAL APPROACH TO

FASCIA ILIACA COMPARTMENT BLOCK –

A RANDOMISED CLINICAL TRIAL

DR . ABHIMANYU SINGH

REG . NO: 1601021006 | AUGUST 2016 | APRIL 2018

M.D Anaesthesiology, MGMCRI

GUIDE

DR . T. SIVASHANMUGAM

PROF ESSOR & HEAD

DEPARTMENT OFANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI

Co-GUIDE

DR . ANNIE SHEEBA . J

ASSI STANT PROF ESSO R

DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MGMCRI

MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

2

CANDIDATE

Candidate Name : DR.ABHIMANYU SINGH

Course of Study : MD ANAESTHESIALOGY

University Identity No : 1601021006

Mobile Phone No : +919999636613

E-mail Address : abhi2690singh@gmail.com

Month/Yr of Admission : JULY 2016

Month/Yr of Examination : APRIL 2019

GUIDES

GUIDE: DR. T. SIVASHANMUGAM

HOD and Professor

Department of Anaesthesiology and Critical Care

9442505567

drsiva95@gmail.com

CO GUIDE: DR. ANNIE SHEEBA. J

Assistant Professor

Department of Anaesthesiology and Critical Care

9655035791

annies@mgmcri.ac.in

3

PART II – THE PROTOCOL

1 INTRODUCTION

Fascia Iliaca Compartment Block (FICB) has been used for perioperative analgesia

in patients undergoing lower limb surgeries particularly hip arthroplasty, femur

fractures and surgeries on the thigh.1To provide better analgesia, all three nerves

supplying the thigh has to be blocked. FICB successfully blocks the femoral and the

lateral femoral cutaneous nerve and some extent involves the obturator nerve.2Fascia

Iliaca Compartment Block is an anterior approach to lumbar plexus and was first

described by dalensin in 1989.Different approaches for FICB has been explained,

conventional infra-inguinal approach by Dalens and the modified supra-inguinal

approach by Stevens.3Studies comparing the two approaches shown that supra-

inguinal FICB has better postoperative analgesia and reduced opioid consumption.In

the supra-inguinal area, the femoral and obturator nerve lie on either side of the psoas

major muscle which can cause better spread of local anaesthetic drug to block

obturator nerve. Whereas in the infra-inguinal region the obturator nerve enters the

obturator foramen to supply medial compartment of thigh and less likely to be

blocked.

Hence this study is designed to identify the incidence of 3-in-1 nerve block in both

supra and infra-inguinal approach to FICB under Ultrasound guidance.

4

AIMS AND OBJECTIVES

Aim:

To quantitatively compare the incidence of 3 nerves block in ultrasound guided

supra-inguinal versus infra-inguinal approach to fascia iliaca compartment block.

Objectives:

Primary Outcome-

a. Incidence of 3nerves block ( Femoral Nerve, Lateral Femoral

Cutaneous Nerve and Obturator Nerve )

Secondary Outcome-

a. Time of onset of block of all three nerves

b. Distance between Supra- inguinal and Infra – inguinal injection

points from inguinal ligament

5

2 REVIEW OF LITERATURE

Kumar et al4 in 2015 conducted a study to compare the analgesic efficacy of

conventional infra-inguinal versus modified proximal supra-inguinal of fascia iliac

compartment block for post op analgesia in total hip arthroplasty. 40 patient

scheduled for THA were recruited for intervention and randomized to receive

landmark guided FICB either by supra inguinal approach (group S) or infra-inguinal

approach (group I) for post-operative analgesia with 40 ml of 0.2% bupivacaine, in

addition to postoperative patient controlled analgesia (PCA) with morphine. Visual

analog scale and PCA morphine consumption was used to access the postoperative

pain at 3, 6, 12 and 24 hours. The primary outcome was cumulative PCA morphine

consumption in 24 hours. The pain intensity measured by VAS score showed

significant reduction of intensity at 6-hour post block in 'group S' than compared to

'group I' but there was no significant difference in VAS at 12 and 24 hours.

Postoperative there is significant difference in time to first PCA morphine demand in

group S v/s group I. The postoperative morphine consumption was also lessin group

S compare to group I at 6, 12 and 24 hours and the cumulative morphine

consumption in 24 hours. They concluded that supra-inguinal FCIB provides better

postoperative analgesia compared infra-inguinal approach.

Capdevila X et al5 in 1998 conducted a radiological and clinical assessment of three

in one and fascia ilica compartment block.The 3-in-1 (Group 1) and fascia iliaca

compartment (Group 2). They recruited 100 adults posted for lower limb surgery.

Pain control, sensory and motor blockades, and radiographically visualized spread of

local anaesthetic solution were studied prospectively. Both approaches provided

6

efficient pain control using 30 mL of 2% lidocainewith adrenaline and 0.5%

bupivacaine and 5 mL of contrast media (iopamidol). Complete lumbar plexus

blockade was achieved in 18 (38%) Group 1 and 17 (34%) Group 2 patients (n = 50

patients per group). Sensory block of the femoral, obturator, genitofemoral, and LFC

nerves was obtained in 90% and 88%, 52% and 38%, 38% and 34%„ and 62% and

90% of the patients in Groups 1 and 2, respectively (P < 0.05). Sensory LFC

blockade was obtained more rapidly for the patients in Group 2 (P < 0.05).

Concurrent internal and external spread of the local anesthetic solution under the

fascia iliaca and between the iliacus and psoas muscles was noted in 62 of the 92

block procedures analyzedradiographically. They concluded that the fascia iliaca

com- partment block is more effective than the 3-in-1 block in producing

simultaneous blockade of the LFC and fem- oral nerves in adults. After both

procedures, blockade was obtained primarily by the spread of local anesthetic under

the fascia iliaca and only rarely by contact with the lumbar plexus. The fascia iliaca

compartment technique provides faster and more consistent simultaneous blockade

of the lateral femoral cutaneous and femoral nerves.

Swenson et al6 conducted radiological evaluation of spread of local anaesthetic and

its effects on obturator nerve when injected deep to the fascia iliaca at the level of

the inguinal ligament. Patients were prospectively studied, and images were

interpreted using a randomized and blinded protocol. Ten patients (ASA 1-2) having

anterior cruciate ligament reconstruction received either 3-in-1 or FI compartment

blocks for postoperative analgesia using the surface landmarks techniques .

Ultrasound was used to position the injecting needle immediately deep to the FI.

Local anesthetic distribution was studied using MRI. Patients were examined for

7

motor and/or sensory function of the femoral, obturator, and lateral femoral

cutaneous nerves. Magnetic resonance imaging was used to document the limits of

injectate distribution. Magnetic resonance imaging showed distribution of injectate

over the surface of the iliacus and psoas muscles to the level of the retroperitoneum.

No patient showed medial extension of injectate to the Obturatornerve . At the level

of the inguinal ligament, injectate extended laterally toward the anterior superior iliac

spine and medially to the femoral vein. All patients had significant weakness with

extension of the knee and sensory loss over the anterior, lateral, and medial thigh. No

patient demonstrated decreased hip adductor strength. Ultrasound and MRI show

consistent superior extension of local anesthetic to the level of the retroperitoneum

for both techniques. There was reliable clinical effect on the femoral and lateral

femoral cutaneous nerves. However, none of the injections produced evidence of ON

block either at the level of the retroperitoneum or the inguinal ligament.

McNamee DA et al7 hypothesized that addition of obturator nerve block to combined

femoral and sciatic nerve block improves the quality of postoperative analgesia for

total knee replacement. They recruited 60 patients posted for Total knee replacement

randomised into two groups. Group 1 received combined femoral- sciatic nerve

block with 15 ml of 0.75% ropivacaine at each nerve. Group 2 received combined

femoral- sciatic nerve block with 15 ml of 0.75% ropivacaine at each nerve and 5 ml

in obturator nerve block. Peripheral nerve blocks were successful in 85% of patients.

The group which received the obturator nerve block showed a significant increase in

the time until their first request for analgesia (mean 257.0 vs. 433.6 min) and a

significant reduction in the total requirements for morphine throughout the study

period (mean 83.8 vs. 63.0 mg) (P<0.05). There were no systemic or neurological

8

sequelae in any of the groups. They concluded addition of an obturator nerve block

to femoral and sciatic blockade improved post-operative analgesia following total

knee replacement.

Olivier Cuignetet al8conducted a randomised, prospective, double- blind study to

assess the efficacy of continuous FICB for pain management in burns patient

undergoing skin grafting from thigh donor site..Twentypatients,withatotalburnsurface

area of 16% ± 13% (mean ± SD) were randomized 1:1 to receive either ropivacaine

0.2% or saline 0.9%. All patients received a general anaesthetic followed by pre-

incision continuous FICB by landmark guided “ double pop” technique and 40 mL of

the randomized solution, then an infusion of 10 mL/h of either ropivacaine or saline

until the first resin change(72hlater) was given.Patientswith continuous FICB had

significantly reduced postoperative morphine consumption at all time points (23± 20

versus 88 ± 29 mg after 72 h, study versus control groups, respectively; P < 0.05). In

both groups, VAS scores remained low but were only significantly lower for patients

with continuous FICB during the first dressing change. They concluded that

continuous FICB is more effient method for diminishing pain at thigh donor site.

9

3 RESEARCH QUESTION OR HYPOTHESIS

Supra – inguinal approach to FacsiaIliaca Compartment can produce higher

incidence of 3 in 1 nerve block compared to Infra- inguinal Approach.

Subjects and Methods

3.1 STUDY SUBJECTS

The Study InvolvesHUMANS

3.2 TYPE OF STUDY

Randomised Clinical Trial

3.3 PLACE OF STUDY

Mahatma Gandhi Medical College and Research Institute

3.4 SELECTION PROCESS

3.4.1 STUDY POPULATION

All patients scheduled for lower limb surgery requiring Fascia Iliaca Compartment

Block for Analgesia

3.4.2 VOLUNTEERS RECRUITEMENT PROCESS

Not Applicable

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3.4.3 INCLUSION CRITERIA

Age 18 to 65 years

ASA I – II

All surgeries requiring FICB for analgesia

3.4.4 EXCLUSION CRITERIA

Patient refusal

Lower limb fracture

Patients allergic to local anaesthetics

Patients with coagulopathy

Patients with neurological deficits and neuromuscular diseases

Patients with infection at the site of injection

Pregnant patients

3.4.5SAMPLING PROCEDURE

60 consecutive patients posted for lower limb surgeries will randomly selected using

a closed envelope technique.

11

3.4.6 STUDY GROUPS

The Number of Groups is:TWO

Specify the Groups:

GROUP- S: This group will receive ultrasound guided supra-inguinal FICB

with 10ml of 2% Lignociane with Adrenaline and 10ml of 0.5% Bupivacaine.

GROUP –I: This group will receive ultrasound guided infra-inguinal FICB

with 10ml of 2% Lignociane with Adrenaline and 10ml of 0.5% Bupivacaine.

3.4.7SAMPLE SIZE

PS Power and Sample Size Calculation Software (Version 3.0 January 2009) was

used to calculate sample size using “Incidence of 3 in 1 block” as primary outcome

variable.

Capdivela X et al showed 34% incidence of 3 in 1 block in infra- inguinal approach

to FICB. To find double this incidence (34% vs. 70%) of 3 in 1 block in supra-

inguinal approach with error of 0.05 and power 0.80, the calculated sample size is 30

patients in each group.

12

3.5 METHODOLOGY / PROCEDURES:

After obtaining approval from the institutional ethical committee and obtaining

patient consent, 60 patients schedule for lower limb surgeries ( fulfilling inclusion

criteria ) will be recruited for this study. All patients will be premedicated with tablet

Alprazolam 0.5 mg, tablet Ranitidine 150 mg, tablet Metoclopromide 10 mg on the

night before and on the morning of surgery. After arrival in the operating theatre,

18G cannula will be secured. Standard monitoring will be used including NIBP,

SpO2, Pulse Oximeter and baseline hemodynamic parameters will be recorded.

Baseline motor assessment for femoral and obturator nerve will be done by the

examiner who will not perform the block. Femoral nerve will be assessed by

Quadriceps manual muscle testing, this will performed by making the patient sit with

knee flexed, hanging freely and back rested against the wall ( to eliminate support

from hip flexors ), examiner will apply pressure on the anterior surface of the leg and

command the patient to extent the knee against the examiner‟s resistance. Similarly,

the technique will be repeated in supine position for gravity eliminated grading (if

required). Obturator Nerve assessment will be done by muscle strength test-adductor

manual muscle testing and adductor squeeze test. Adductor manual muscle test will

be done by placing the patient on lateral decubitus position with the leg to be

assessed on the non-dependent side with 450

abduction. Resistance will be applied on

the medial surface of the leg by the examiner and patient will be instructed to adduct

the test leg towards dependent leg against resistance. Similarly, the test will be

performed in supine position to eliminate gravity (if required). Adductor squeeze test

will be done by placing the patient in supine position with knee flexed to 450 and a

commercially available stabilizer bag- pressure biofeedback ( pre-inflated to

13

40mmHg ) will be placed between the thighs and patient will be instructed to

squeeze the bag as hard as possible and the pressure exerted will be noted from the

pressure gauge attached to the stabilizer bag.

After the initial assessment, patient will be randomisedbased on the allocation

number using closed envelope technique. Patient will be prepared for the FICB

procedure and the distance from supra- inguinal and infra- inguinal injection points

from the ligament will be measured using ultrasound.

GROUP S (supra-inguinal approach):

Patient will be in positioned supine with legs slightly abducted. After strict aseptic

precaution, SonositeXporte ( Sonosite, Bothwell, WA) ultrasound system with multi-

beam (compound array) capability and with high frequency linear array transducer

( HFL 50, 15-10 MHz) will be used to perform the block. The USG probe will be

placed on the inguinal ligament and scanned upwards till the iliacus muscle, fascia

iliaca, external iliac vessels and femoral nerve are identified and distance from this

point to the inguinal ligament will be noted. 23G spinal needle will be introduced in

an in-plane approach towards femoral nerve below fascia iliaca and a total volume

20ml Local anaesthetic drug will be injected after negative aspiration of blood and

under ultrasound imaging.(2% Lignocaine with Adrenaline and 10ml of 0.5%

Bupivacaine)

GROUP I:

Patient will be in positioned supine with legs slightly abducted. After strict aseptic

precaution, SonositeXporte( Sonosite, Bothwell, WA) ultrasound system with multi-

beam (compound array) capability and with high frequency linear array transducer

(HFL50, 15-10 MHz) will be used to perform the block. The USG probe will be

placed on the inguinal ligament and scanned downwards until the femoral vessels,

14

femoral nerve are identified. The point of injection will be just above the level of

division of femoral artery close to femoral nerve depositing the drug below the fascia

iliaca. This distance will be noted. 23G spinalneedle will be introduced in an in-

plane approach towards femoral nerve below fascia iliaca and a total volume 20 ml

local anaesthetic drug will be injected after negative aspiration of blood and under

ultrasound imaging. (2% Lignocaine with Adrenaline and 10ml of 0.5%

Bupivacaine)

Patient will be continuously monitored and hemodynamic parameters recorded every

10 minutes. The motor and sensory assessment after the block, will be done by the

examiner blinded to the approach used for FICB. Sensory assessment will be done at

30, 45 and 60 minutes after block. Sensation to cold will be noted in area of sensory

distribution of the three nerves- Femoral Nerve assessed on the anterior surface of

the thigh, Lateral Femoral Cutaneous Nerve on the lateral surface of the upper thigh

and Obturator Nerve on the the medial surface of the thigh and the postero-medial

surface of the knee. Motor assessment for quadriceps muscle and adductor muscle

strength will also be repeated at 30, 45 and 60 minutes. The scores will be recorded

on the data collection sheet. After 60 minutes of assessment and monitoring, patient

will be given surgical anaesthesia for the planned procedure by the in-charge OT

anaesthesiologist. A successful 3 nerve block is considered when the sensory

assessement score for cold sensation is 0 and motor power score for quadriceps and

adductor muscles is 1-0 and 50% decrease in pressure generated by adductor squeeze

test at the end of 60 minutes after block.

15

60 patients posted for lower limb surgeries

Ethical committee approval

and informed consent

Fulfilling inclusion criteria

Premedication

18G IV, standard monitoring- ECG, SpO2, NIBP

Randomisation by sealed envelope technique

GROUP S

USG guided Supra-inguinal FICB

Distance between supra and infra-inguinal injection point from

inguinal ligament will be measured with USG guidance

LA Dose: 10ml of 2% Lignocaine with Adrenaline and 10ml of

0.5% Bupivacaine

Sensory and motor assessment will be done at 30, 45, 60 minutes after Block by

examiner blinded to the procedure.

Patient will receive anaesthesia for surgery as per OT anaesthesiologist

Quadriceps and adductor muscle strength test ( examiner)

GROUP I

USG guided Infra - inguinal FICB

16

3.5.1 INTERVENTIONS/DRUGS USED

DRUGS:

10ml of 2% Lignocaine with Adrenaline and 10ml of 0.5% Bupivacaine.

PROCEDURE:

Ultrasound guided fascia iliaca block will be performed either in a supra- inguinal

region or infra- inguinal region based on the randomisation. Once the site of injection

is identified by USG guidance, 20ml of Local Anaesthetic drugwillbedepositedbelow

the fascia Iliaca. (2% lignocaine with adrenaline and 0.5% Bupivacaine)

3.5.2 PROCUREMENT OF INVESTIGATIONAL DRUGS,

STORAGE, DISPENSING, ETC.

Available from Pharmacy

3.6 STUDY TERMINATION

The study will be terminated after adequate number of cases are achieved.

4 STUDY VARIABLES

1. Dependent Variable :

Incidence of 3 nerves block

Time of onset of 3 nerves block

Extent of sensory Blockade

Quadriceps and Adductor Muscle Strength

Distance of injection site from inguinal ligament

17

2. Independent Variables:

Age

Sex

BMI

4.1 DATA COLLECTION

Data will be entered into a Data collection Proforma Sheet (Appendix 1) and entered

into Excel (MS Excel 2013). Secondary Data will be collected from patient records.

Privacy and Confidentiality will be maintained throughout. All patient identifiable

numbers and information will be stripped and replaced by anonymous numbers.

S. No Name of the dependent /

independent variables

Scale of measurement

(Quantitative / qualitative)

Descriptive / Inferential

Statistics to be used

1 3 in 1 block Quantitative Mean, SD, Independent t

test

2 Sensory Blockade Quantitative Mean, SD, Independent t

test

3 Quadriceps muscle strength test Quantitative Mean, SD, Independent t

test

4 Adductor muscle strength test Quantitative Mean, SD, Independent t

test

5 Distance between injection point

and inguinal ligament

Quantitative Mean, SD, Independent t

test

6 Age Quantitative Mean, SD, Independent t

test

7 Sex Qualitative Percentage , chi square test

8 BMI Quantitative Mean, SD, Independent t

test

18

4.2 STATISTICAL METHODS

Parametric data will be analysed using student t test.

Non-parametric data will be analysed by chi square test.

5 REFERENCES

1) DalensB, Vanneuville G, Tanguy A. Comparison of the fascia iliaca

compartment block with the 3-in-1 block in children. AnesthAnalg 1998;

69,705-713

2) Diwan S. Fascia Iliaca Block- An anatomical and Technical Description.

Journal of Anaesthesia And Critical Care Case Reports.2015; 1(1):27-30.

3) Stevens M, Hrrison G, McGrail M. A modified fascia iliaca compartment

block has significant morphine sparing effects. Anaesth. Int. Care 2007;35:

949-952

4) Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V.

Comparison of conventional infra-inguinal versus modified proximal supra-

inguinal approach of Fascia Iliaca Compartment Block in Total Knee

Replacement. ActaAnaesthesiolBelg 2015; 66(3):95-100.

5) X. Capdevila, Biboulet, M. Bouregba, Y. Barthelet, J. RubenovitchF.

d‟Athis.Comparison of the Three-in-One and Fascia lliaca Compartment

Blocks in Adults: Clinical and Radiographic Analysis. AnesthAnalg

1998;86:103944)

6) Swenson JD, Davis JJ, Stream JO, Crim JR, Burks

RT, GreisPE.Localanesthetic injection deep to the fascia iliaca at the level of

19

the inguinal ligament: the pattern of distribution and effects on the obturator

nerve. Ream Act Anaesth 2005; 11: 86-91.

7) Mcnamee DA, Parks L, Milligan KR. Post-operative analgesia following total

knee replacement: an evaluation of the addition of an obturator nerve block to

combined femoral and sciatic nerve block.ActaAnaesthesiol. Scand 2002; 46

(1) :95-9

8) Olivier Cuignet,, Jean Pirson,, Jenna Boughrouph,, and Diane Duville. The

Efficacy of Continuous Fascia Iliaca Compartment Block for Pain

Management in Burn Patients Undergoing Skin Grafting

ProceduresAnesthAnalg2004;98: 1077–81.

6 PRELIMINARY WORK DONE ALREADY

Review of literature, data collection form and consent form.

7 ETHICAL ISSUES

This study aims to identify which of the two techniques causes increases chances of

3 in 1 nerve block in lower limb. The drug to be used is already approved and found

safe for nerve block.

Study involves Humans

20

8 INFORMED CONSENT PROCEDURE

Patient information and informed consent form isattached as APPENDIX 2

9 QUALITY CONTROL

Name: Dr.HemanthKumar.V

Designation: Professor

Department of Anaesthesiology and Critical Care

Telephone No: 9003550553

E-mail:hemanthkumarvr@mgmcri.ac.in

10 SPONSORSHIPS

a. Sponsors for the study: NONE

b. Outside funding: NONE

21

11 INVESTIGATORS DECLARATION

This is to certify that the protocol entitled “Comparative Evaluation Of

Ultrasound Guided Supra- inguinal v/s Infra-inguinal Approach to Fascia Iliaca

Compartment Block – A Randomised Clinical Trial” was reviewed by us for

submission to the SBV Institutional Ethics Committee and certified that this protocol

represents an accurate and complete description of the proposed research. Wehave

read the ICMR guidelines, ICP-GCP guidelines/CPCSEA guidelines/and other

applicable guidelinesand undertake to ensure that the rights and welfare of the study

subjects are protected.

The study will be performed as per the approved protocol only. If any deviation is

warranted, the same will be presented to the ethical committee and permission will

be sought. We assure that the study will be terminated immediately in case of any

unforeseen adverse consequences and we will inform the same to the ethical

committee immediately.

Dr. T. Sivashanmugam (For HOD)

Professor and Head of

Department of Anaesthesiology 18/11/2016

Dr. Annie Sheeba.J

Assistant Professor of Anaesthesiology

18/11/2016

Dr. Abhimanyusingh

Department of Anaesthesiology

18/11/2016

Dr. Head of Department (For HOD)

Head ofDepartment of Speciality

with Dept. Seal 18/11/2016

22

APPENDIX 1

MATHAMA GANDHI MEDICAL COLLEGE AND RESERCH INSTITUTE

PONDICHERRY

DATA COLLECTION PROFORMA

COMPARATIVE EVALUATION OF ULTRASOUND GUIDED SUPRA

INGUINAL V/S INFRA INGUINAL APPROACH TO FASCIA ILIACA

COMPARTMENT BLOCK –

A RANDOMISED CLINICAL TRIAL

NAME

AGE / SEX/ BMI

WEIGHT

HOSPITAL NO

DIAGNOSIS

SURGICAL PROCEDURE

COMORBID ILLNESS

ASA

COMPLICATION

ALLOCATION NMBER

23

SENSORY

ASSESMENT

15 MINUTS 30 MINUTS 45 MINUTS 60 MINUTS

FEM.

N

OB.

N

LFC.

N

FEM.

N

OB.

N

LFC.

N

FEM.

N

OB.

N

LFC.

N

FEM.

N

OB.

N

LFC.

N

COLD SWAB

TEST

MOTOR

ASSESMENT

PRE BLOCK

POST BLOCK

15 MINUTS 30 MINUTS 45 MINUTS 60 MINUTS

QUADRICEP

MUSCLE

STRENGHT

ADDUCTOR

SQUEEZE

TEST

FAILED BLOCK:- YES / NO

3 NERVES BLOCKED:- YES / NO

NO, NERVES SPARED:-

SENSORY ASSESMENT

2 PERCEIVES BOTH TOUCH AND TEMPRATURE

1 PERCEIVES ONLY TOUCH NOT GEMPRATURE

0 NEITHER PERCEIVES TOUCH NOR TEMPRATURE

MOTOR ASSESMENT

2 NORMAL POWERE ( 5/5 , 4/5 )

1 WEAKNESS AGAINST RESISTANCE ( 3/5 , 2/5 )

0 NO MOTOR FUNCTION ( 1/5 , 0/5 )

24

25

APPENDIX 2

INFORMATION SHEET FOR THOSE WHO PLAN TO PARTICIPATE IN

THE RESEARCH PROJECT

NAME OF THE RESEARCH PROJECT:

“COMPARATIVE EVALUATION OF ULTRASOUND GUIDED SUPRA

INGUINAL V/S INFRA INGUINAL APPROACH TO FASCIA ILIACA

COMPARTMENT BLOCK - A RANDOMISED CLINICAL TRIAL”

We welcome you and thank you for having accepted our request to consider whether

you can participate in our study. This sheet contains the details of the study; the

possible risks, discomfort and benefits for the participants are also given. You can

read and understand by yourself; if you wish, we are ready to read and explain the

same to you.If you do not understand anything or if you want any more details we

are ready to provide the details. The purpose of my study is to find out the nerves

getting blocked while giving local anaesthetics drug at the level groin region (region

between the abdomen and the thigh). An injection with local anaesthetic drug at the

level of the groin will block the sensation through the nerves arising from there.

There are three nerves giving sensation to the skin over the thigh and the thigh

muscle. By blocking these nerves with drugs, pain relief after surgery will be better.

We intend to identify whether all three nerves get blocked while giving the drug

above or below the groin region. This study is being conducted by me, Dr.

Abhimanyu Singh a Post Graduate medical student belonging to the department of

Anaesthesialogy and Critical Care, under the guidance of Dr. T Shivashanmugam.

Professor and Head of Department of Anaesthesialogy and Critical Care, MGMC &

RI, Pondicherry. You am being considered as one of the participant Because you have

26

been referred to PAC (Department of Anaesthesialogy and Critical Care) for lower limb

surgery and you are fulfilling the criteria of this study. The choice is yours. If you do not

wish to participate you will not be included in this study. Even then, you will continue to get

the proposed medical treatment without any prejudice. After understanding the details of

the study, you should give us your written consent. You have to permit us to utilize your

clinical data and co-operation during procedure. Yes, the study will provide you longer

painless postoperative period and in the management of pain for the public in future .

There are no forcible risk or discomfort involving in the study because the drug has

been approved for use in the nerve blocks and has been proven to be safe.. you will

not be paid for the study. Your confidentiality will be maintained. if you want you can

get the details from us. You can withdraw at any time during the study period.

27

MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE PUDUCHERRY

FORM FOR GETTING INFORMED CONSENT FOR THOSE PARTICIPATING IN THE RESEARCH PROJECT

Name of the Research Project:- COMPARATIVE EVALUATION OF ULTRASOUND GUIDED SUPRA

INGUINAL V/S INFRA INGUINAL APPROACH TO FASCIA ILIACA

COMPARTMENT BLOCK – A RANDOMISED CLINICAL TRIAL I _______________________ have been informed about the details of the study in own language. I have understood the details about the study. I know the possible risks and benefits for me, by taking part in the study. I understand that I can withdraw from the study at any point of time and even then, I will continue to get the medical treatment as usual. I understand that I will not get any payment for taking part in this study. I will not object if the results of this study is getting published in any medical journals, provided my personal identity is not reviewed. I know what I am suppose to do by taking part in this study and I assure that I will give my full co-operation for this study. Signature/Thumb impression of the participant (Name/Address) ___________________________________ ___________________________________ ___________________________________ Name & Signature of the investigator ___________________________________ ___________________________________

28

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