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CTRI Number  CTRI/2025/08/093556 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two types of nerve blocks for better pain relief and comfort during spinal anesthesia in patients undergoing surgery for thigh bone (hip) fracture. 
Scientific Title of Study   Comparison of the Analgesic Effect of Ultrasound-Guided Suprainguinal Fascia Iliaca Block (SIFI) Versus Femoral Nerve Block (FNB) for Positioning During Central Neuraxial Block in Patients Undergoing Proximal Femur Fracture Surgery: A Double-Blinded Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi M 
Designation  PG student 
Affiliation  pondicherry institute of medical science 
Address  Pondicherry Institute of Medical Sciences (PIMS),Department of anaesthesiology, Village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India

Pondicherry
PONDICHERRY
605014
India 
Phone  9442885434  
Fax    
Email  swathi02597@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRRAMYAVEL 
Designation  Professor ,Department of anaesthesiology. 
Affiliation  pondicherry institute of medical science 
Address  Pondicherry Institute of Medical Sciences (PIMS),Department of anaesthesiology, Village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India

Pondicherry
PONDICHERRY
605014
India 
Phone  9487630425  
Fax    
Email  ramyavel1988@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRRAMYAVEL 
Designation  Professor ,Department of anaesthesiology. 
Affiliation  pondicherry institute of medical science 
Address  Pondicherry Institute of Medical Sciences (PIMS),Department of anaesthesiology, Village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India

Pondicherry
PONDICHERRY
605014
India 
Phone  9487630425  
Fax    
Email  ramyavel1988@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences (PIMS) village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences (PIMS) is located at Village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India 
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 Swathi M  Department of Anaesthesiology ,Pondicherry Institute of Medical Sciences .  Pondicherry Institute of Medical Sciences (PIMS) village No. 20, Ganapathichettikulam, Kalapet, Puducherry - 605014, India
Pondicherry
PONDICHERRY 		 09442885434

swathi02597@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute ethics committe(IEC)itee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  femoral nerve block   Patients will be given 20ml of 0.2 percenatage ROPIVACAINE & 2ml of DEXAMETHASONE (8mg) in Ultrasound Guided Femoral Nerve Block (FNB) 20minutes prior to positioning for Central Neuraxial Blockade 
Intervention  suprainguinal fascia iliaca block   Patients will be given 30ml of 0.2 Percenatge ROPIVACAINE & 2ml of DEXAMETHASONE (8mg) in Ultrasound Guided Femoral Nerve Block (FNB) 20minutes prior to positioning for Central Neuraxial Blockade. These will be performed by independent Anaesthesiologist who is not part of the study.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Elective procedures of proximal femur fracture surgeries under central blockage
2. Patients belonging American Society of Anaesthesiologist (ASA) physical status of l- lll
 
 
ExclusionCriteria 
Details  ,1. Inability to comprehend Numerical Rating Score
2. Patients with Coagulopathies
3. Patients on treatment for chronic pain 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic effect of ultrasound guided suprainguinal fascia iliaca block versus femoral nerve block using Numerical Rating Scale (NRS) at rest for performing central neuraxial block in patients undergoing proximal femur fracture surgery.
 		 Numerical rating scale (NRS)pain measured at Rest ,15 degree passive leg raise at 5,10,15,20 minutes before spinal anaesthesia .  
 
Secondary Outcome  
Outcome  TimePoints 
1)The pain using Numerical Rating Scale at the time of positioning between the 2 groups.
2)The hemodynamic parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, Oxygen saturation) pre-intervention, from the time of nerve block till central neuraxial block between the 2 groups.
3)The patient satisfaction score at the time of positioning between the 2 groups
 		 measured at Rest , 5,10,15,20 minutes before spinal anaesthesia .  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   06/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study is a double-blinded, randomized controlled trial on proximal femur fracture patients after ethical clearance and informed consent. Patients are randomized into two groups (SIFI block vs. femoral nerve block) using computer-generated numbers and sealed envelopes. A thorough preoperative evaluation, investigations, and counseling regarding the procedure are performed. Standard fasting guidelines and prophylactic medications are followed.

Intraoperatively, patients are monitored with ASA standard monitors, and baseline parameters are recorded. Group A receives an ultrasound-guided suprainguinal fascia iliaca block with 30 ml 0.2% ropivacaine + dexamethasone, while Group B receives an ultrasound-guided femoral nerve block with 20 ml 0.2–0.25% ropivacaine + dexamethasone. Pain (NRS) and hemodynamic parameters are assessed up to 20 minutes post-block. Rescue fentanyl is administered if NRS >4.

Central neuraxial blockade follows: an epidural catheter is placed at L2/L3 and tested with lignocaine-adrenaline, followed by spinal anesthesia at L3/L4 using 0.5% heavy bupivacaine. Adequate analgesia (paracetamol) and hemodynamic stability are ensured. Post-surgery, patients are shifted to HDU for monitoring and pain management.

 
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