FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013587 [Registered on: 01/05/2018] Trial Registered Retrospectively
Last Modified On: 22/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of local anaesthetic drug injection at two points in the junction of thigh and abdomen- one point above the junction and second below the junction to assess the blockade of nerves supplying the thigh. 
Scientific Title of Study   Comparative Evaluation Of Ultrasound Guided Supra Inguinal Versus Infra Inguinal Approach To Fascia Iliaca Compartment Block – A Randomised Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhimanyu Singh 
Designation  Postgraduate ( MD Anaestheiology) 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9999636613  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Annie Sheeba J 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  annie.john24@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Annie Sheeba J 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Research Institute Pillayarkuppam

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  annie.john24@yahoo.co.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute Pillayarkuppam Pondicherry - 607403 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute 
Address  Mahatma Gandhi Medical College and Research Institute Pillayarkuppam Pondicherry - 607403 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhimanyu Singh  Mahatma Gandhi Medical College and Research Institute  Department of Anaesthesiology Second floor, D block Hospital complex, Mahatma Gandhi Medical College and Research Institute Pillayarkuppam
Pondicherry
PONDICHERRY 		 9999636613

dr.anniej@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients posted from lower limb surgeries requiring post operative analgesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infra-inguinal Fascia Iliaca Compartment Block   A Infra-inguinal fascia iliaca block will be given and blockade of the three nerves of the thigh will be noted- Femoral nerve, Obturator nerve, Lateral femoral cutaneous nerve. Procedure will be for 45 minutes 
Intervention  Supra- Inguinal Fascia iliaca block   A supra-inguinal fascia iliaca block will be given and blockade of the three nerves of the thigh will be noted- Femoral nerve, Obturator nerve, Lateral femoral cutaneous nerve. procedure will be for 45 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) ASA I – II
2) All surgeries requiring FICB for analgesia
 
 
ExclusionCriteria 
Details  1) Patient refusal
2) Lower limb fracture
3) Patients allergic to local anaesthetics
4) Patients with coagulopathy
5) Patients with neurological deficits and neuromuscular diseases
6) Patients with infection at the site of injection
7) Pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of 3 nerves block -
1) sensory Blockade
2) quadriceps muscle strenght
3) adductor squeeze test 		 outcome will be assessed every 15 minutes for one hour 
 
Secondary Outcome  
Outcome  TimePoints 
1) Time of onset of block of all three nerves
2) Distance between Supra- inguinal and Infra – inguinal injection points from inguinal ligament
 		 1) Every 15 minutes after the block
2) one time before performance of the block  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/04/2017 
Date of Study Completion (India) 10/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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.

After the initial assessment, patient will be randomised based 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.

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

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.

 
Close