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CTRI Number  CTRI/2022/05/042774 [Registered on: 24/05/2022] Trial Registered Prospectively
Last Modified On: 30/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effects of two approches of giving ultrasound guided fascia iliaca compartment block, using ropivacaine as local anaesthetic drug in patients undergoing surgery for various types of hip fractures. 
Scientific Title of Study   A comparative study of post operative analgesic efficacy of suprainguinal versus infrainguinal approach of usg guided fascia iliaca compartment block using 0.2% ropivacaine in patients undergoing surgery for hip fracture under spinal anesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ananda Prakash Banerjee 
Designation  Post graduate resident  
Affiliation  Jawaharlal Nehru medical college and hospital  
Address  Department of anaesthesiology, New OT, JLN medical college, Ajmer.

Ajmer
RAJASTHAN
305001
India 
Phone  9711536560  
Fax    
Email  banerjee200@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Mathur 
Designation  Professor  
Affiliation  Jawaharlal Nehru medical college and hospital 
Address  Department of anaesthesiology, New OT, JLN medical college, Ajmer.

Ajmer
RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Mathur 
Designation  Professor  
Affiliation  Jawaharlal Nehru medical college and hospital 
Address  Department of anaesthesiology, New OT, JLN medical college, Ajmer.


RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru medical college and hospital 
 
Primary Sponsor  
Name  Jawaharlal Nehru medical college and hospital 
Address  Department of anaesthesiology, JLN medical college and hospital, Ajmer, Rajasthan. 
Type of Sponsor  Government 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 Ananda Prakash Banerjee  Jawaharlal Nehru medical college and hospital  New OT, Department of Anaesthesiology JLN medical college, Ajmer
Ajmer
RAJASTHAN 		 9711536560

banerjee200@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S721||Pertrochanteric fracture, (3) ICD-10 Condition: S722||Subtrochanteric fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infrainguinal approach of usg guided fascia iliaca compartment block  In the supine position as before, a high frequency (6–14 MHz) linear probe is placed transversely to identify the femoral artery at the inguinal crease. The iliopsoas muscle with the overlying fascia iliaca is identified and the hyperechoic FN is typically seen lying between the iliopsoas and fascia iliaca at a depth of 2–4 cm, lateral to the femoral artery. The probe is tilted cranially and caudally until optimal images of the FN and fascia iliaca are obtained. The triangular shaped sartorius muscle and the ASIS are identified on moving the probe. A 100 mm blunt ended needle is inserted using an in-plane technique with the aim of placing the needle tip beneath the fascia iliaca around the lateral third of a line between the ASIS and pubic tubercle. Aspiration is performed before injection of 1–2 ml LA. Correct needle placement is confirmed by separation of the fascia iliaca from the iliopsoas muscle with LA spreading towards the FN medially and the iliac crest laterally. A volume of 40 ml 0.2% ropivacaine is used for this block.  
Intervention  Suprainguinal approach of usg guided fascia iliaca compartment block  With the patient supine, a linear high frequency probe (6-14 MHz) is placed in the sagittal plane to obtain an image of the ASIS. The probe is moved medially and the fascia iliaca and sarto- rius, iliopsoas, and internal oblique muscles are identified. After identifying the ‘bowtie sign’ formed by the muscle fasciae, a 100 mm needle is introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the needle tip is positioned beneath the fascia iliaca, and hydro-dissection is used to separate the fascia iliaca from the iliacus muscle. The needle is further advanced in this space in a cranial and slightly dorsal direction. The deep circumflex artery lies superficial to the fascia iliaca and upward movement of this artery upon injection. Spread of LA is observed cranial to the point where the iliac muscle passes under the abdominal muscles. A volume of 40 ml of 0.2% ropivacaine is used to block all three nerves using this approach. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1) Patients belonging to ASA (American Society of Anaesthesiologists) class-I, II and III.
2) Patients undergoing hip surgeries of duration 1-3 hours with haemoglobin at least 9 gm/dl and platelet count more than 1lac.
 
 
ExclusionCriteria 
Details  1)Patients not willing to participate in the study.
2)Uncooperative patients.
3)Patient with chronic pain or on long-term analgesics.
4)Any known hypersensitivity or contraindication to ropivacaine or any other local anesthetic.
5)Local pathology at the site of injection or disability limiting the performance of block.
6)Pregnant, lactating mothers.
7)Inadequate block necessitating institution of general anaesthesia for continuation of surgical procedure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of post operative assessment of effective analgesia in both the groups with the help of numeric rating scale NRS score in the first 24 hours.  Around 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess sensory and motor block.
To assess quality of recovery.
To assess patients having any adverse effects or complications. 		 Around 1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) 31/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A STUDY TO COMPARE THE POST OPERATIVE ANALGESIC EFFICACY OF SUPRAINGUINAL VERSUS INFRAINGUINAL APPROACH OF USG GUIDED FASCIA ILIACA COMPARTMENT BLOCK USING 0.2%ROPIVACAINE IN PATIENTS UNDERGOING SURGERY FOR HIP FRACTURE UNDER SPINAL ANAESTHESIA.

 
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