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CTRI Number  CTRI/2023/11/059514 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 28/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing ultrasound guided Femoral Nerve Block and Fascia Iliaca compartment block by a junior doctor for positioning during Spinal Anaesthesia in Femur Fracture surgery 
Scientific Title of Study   A Comparative evaluation of Ultrasound guided Femoral Nerve Block and Fascia Iliaca Block by a novice practitioner for positioning during Spinal Anaesthesia in Femur Fracture surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR. MADHAVI CHAUDHARI 
Designation  PROFESSOR AND HEAD, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  PRAMUKH SWAMI MEDICAL COLLEGE, BHAIKAK UNIVERSITY,  
Address  DEPARTMENT OF ANAESTHESIOLOGY, HM PATEL CENTER FOR MEDICAL CARE AND EDUCATION, KARAMSAD, ANAND Anand

Anand
GUJARAT
388325
India 
Phone  9427084963  
Fax    
Email  madhavic@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  DR JAY SODANI 
Designation  RESIDENT 
Affiliation  H M PATEL CENTER FOR MEDICAL CARE AND EDUCATION 
Address  DEPARTMENT OF ANAESTHESIOLOGY, HM PATEL CENTER FOR MEDICAL CARE AND EDUCATION, KARAMSAD, ANAND Anand

Anand
GUJARAT
388325
India 
Phone  7069776152  
Fax    
Email  jay.sodani96@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR JAY SODANI 
Designation  RESIDENT 
Affiliation  H M PATEL CENTER FOR MEDICAL CARE AND EDUCATION 
Address  DEPARTMENT OF ANAESTHESIOLOGY, HM PATEL CENTER FOR MEDICAL CARE AND EDUCATION, KARAMSAD, ANAND Anand

Anand
GUJARAT
388325
India 
Phone  7069776152  
Fax    
Email  jay.sodani96@gmail.com  
 
Source of Monetary or Material Support  
SHREE KRISHNA HOSPITAL, PRAMUKH SWAMI MEDICAL COLLEGE, KARAMSAD, ANAND, GUJARAT 
 
Primary Sponsor  
Name  SHREE KRISHNA HOSPITAL 
Address  SHREE KRISHNA HOSPITAL, KARAMSAD, ANAND 
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 Madhavi Chaudhari  Pramukh swami medical college  Department of anaesthesiology, Pramukh Swami Medical College
Anand
GUJARAT 		 9427084963

madhavic@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided fascia iliaca compartment bloc  30 ml of local anaesthetic Inj Ropivacaine 0.5% over 5 minutes amd before 30 minutes of positioning for spinal anaesthesia 
Intervention  Ultrasound guided femoral nerve block  30 ml of local anaesthetic Inj Ropivacaine 0.5% over 5 minutes amd before 30 minutes of positioning for spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult patients aged 18-90 years. Patients scheduled for unilateral femur fracture surgery. Patients undergoing spinal anesthesia for femur fracture surgery. Patients who are able to provide informed consent. Patients with ASA status I, II and III 
 
ExclusionCriteria 
Details  Patients with a known allergy to the local anesthetic agents used for the nerve blocks. Patient having local site infection and coagulopathy. Patients requiring epidural anaesthesia along with spinal anaesthesia. Patients undergoing surgery under general anaesthesia. Patients who are pregnant or breastfeeding. Patients with raised ICP and fixed low cardiac output state. Patients with deranged coagulation profile 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the ease to perform the block by a novice practitioner and To compare the NRS scores  0 minutes, 20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the onset & duration of analgesia provided by femoral nerve block & fascia iliaca compartment block.  0 minutes, 20 minutes 
Number of intrathecal needle pricks required to perform successful lumbar puncture in sitting position.  NA 
To compare complications (hematoma, systemic LA toxicity and drug allergy) between both the groups  NA 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
After obtaining institutional ethics committee approval and written and informed consent from patients of ASA I, II or III who will be undergoing femur fracture surgery under spinal anaesthesia will be recruited to participate in this study.

Participants will be allotted in to two groups through balanced randomization. A computer software viz. WINPEPI will be used for the randomization. The treatment allocation will be kept in a sealed opaque envelops and they will be opened after written informed consent of eligible participants. Pre anaesthetic check-up will be carried out in all patients.
Using a sealed envelope technique, patients will be randomly assigned into two groups.
  • Group 1: Will receive FNB with Inj Ropivacaine 0.5% 30 ml
  • Group 2: Will receive FICB with Inj Ropivacaine 0.5% 30 ml
In the procedure room, Standard monitoring- electrocardiogram, pulse oximetry and noninvasive blood pressure will be attached and baseline vitals and NRS will be noted. In the supine position and under all aseptic precautions, the block will be performed by a novice practitioner using ultrasound guidance.

Following equipments will be required:
A portable sterile tray containing:
  • Sterile towel and gauze packs
  • Sterile gloves
  • Bowls containing povidone iodine
  • Sterile syringes of 5ml and 10 ml
  • Sterile needle 18G and 24G
  • Sterile 23G quincke’s spinal needle
  • Tegadum
  • Spirit, Gel
  • Ultrasound machine
  • Local anaesthetic solution- Inj Ropivacaine 0.5%, volume 30 ml
In group 1 patient’s, the linear transducer will be placed transversely on femoral crease to locate femoral artery and nerve. Once the femoral nerve is identified and the local skin infiltration is given, the 23G spinal needle is inserted in a lateral to medial orientation and towards the femoral nerve. Once the needle tip is adjacent to the nerve, after negative aspiration for blood, 30 ml of local anaesthetic Inj Ropivacaine 0.5% injected slowly.

In group 2 patient’s, a line connecting anterior superior iliac spine and pubic symphysis will be drawn and dividing this line into thirds. The needle will be inserted 1 cm lateral to the intersection of the medial two thirds and lateral one third and local skin infiltration is given. The 23G spinal needle will be inserted and advanced perpendicular to the skin till the needle transverses both fascia lata and fascia iliaca of the thigh. After penetrating fascia iliaca, 30 ml of local anaesthetic Inj Ropivacaine 0.5% injected slowly after negative aspiration for the blood.
The time taken from the needle prick to the complete administration of drug will be recorded as the performance time of the block. The onset time of block will be noted. Patient will be assessed for any local systemic toxicity and after 20 minutes of block NRS score will be noted.

Patient will be shifted to operation theatre and NRS score will be noted again before giving position for spinal anaesthesia. Patient will be given sitting position for spinal anaesthesia after NRS score
 
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