| CTRI Number |
CTRI/2026/03/106473 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Suprainguinal Fascia Iliaca Block With Femoral and Lateral Femoral Cutaneous Nerve Block for Positioning Patients Before Spinal Anesthesia |
|
Scientific Title of Study
|
Comparison of Suprainguinal Fascia Iliaca Block With Femoral and Lateral Femoral Cutaneous Nerve Block for Positioning Patients Prior to Spinal Anesthesia in Patients With Fracture Femur A Double Blinded Randomised 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 |
Venkatesh Dilip Bhalerao |
| Designation |
Junior Resident |
| Affiliation |
Venkatesh Bhalerao |
| Address |
Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7738771219 |
| Fax |
|
| Email |
venkatesh.bhalerao999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Borkar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8237641594 |
| Fax |
|
| Email |
anjaliborkar93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Borkar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, Wanadongri, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8237641594 |
| Fax |
|
| Email |
anjaliborkar93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Venkatesh Bhalerao |
| Address |
Department of Anaesthesiology,Datta Meghe Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, Wanadongri, Nagpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VENKATESH BHALERAO |
Shalinitai Meghe Hospital and Research Centre |
Department of Anaesthesiology, Shalinitai Meghe Hospital And Research Centre,Hingha Road,Wanadongari,Nagpur,Maharashtra,Pin-441110
Nagpur
MAHARASHTRA |
7738771219
venkatesh.bhalerao999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group SRD
Group FRD |
Patients will be separated into two categories.
•Group SRD: 30 Patients receiving SIFICB WITH 0.5% 20ML ROPIVACAINE+2ML DEXAMETHASONE
•Group FRD: 30 Patients receiving FNB + 0.5% ROPIVACAINE 20ML + 2ML DEXAMETHASONE
|
| Intervention |
Suprainguinal Fascia Iliaca Compartment Block (SIFICB) performed under ultrasound guidance.
Femoral nerve block (targeting femoral + lateral femoral cutaneous nerve) under ultrasound guidance.
|
After obtaining informed written consent, patients were randomized into one of the two groups. All blocks will be performed in the preoperative holding area under standard monitoring (ECG, NIBP,SpO2).Upon the patients entry into the operation theatre, the Numerical Rating Scale (NRS) pain score will be evaluated and labelled as T0 by using standard 10 points Numerical rating scale, where 0 indicates no pain and 10 reflects the worst pain imaginable. The region of nerve blockade will be cleaned with povidone-iodine and will be draped. A linear 7–13 MHz ultrasound probe will utilize an in-plane technique for advancing an 20G needle. The probe will be shifted laterally or medially and rocked back and forth until a clear image is acquired. The mark on the probe will always be maintained on the lateral side for image alignment. Optimal gain, depth, and focal point were adjusted to achieve the clearest possible visualization of the relevant anatomical structures.
Group SRD (n = 30) undergoing ultrasonography (USG) SIFICB. Landmarks involved recognizing the femoral artery, iliopsoas muscle, fascia iliaca, and sartorius muscle, followed by injecting 2% Ropivacaine 20ML + 2ML Dexamethasone after careful aspiration between fascia iliaca and iliopsoas muscle, near the femoral nerve.
Group FRD (n = 30) undergoing USG GUIDED FNB visualized between the tensor fasciae latae muscle and the sartorius muscle , 1–2 cm medial and inferior to the anterior superior iliac spine (ASIS) and 0.5–1.0 cm deep to the skin surface. FNB 20ML 2% ROPIVACAINE 20ML + 2ML DEXAMETHASONE
Again ,Patient’s NRS score will be evaluated after the block procedure, 20 minutes post-block, during positioning for SAB. Anaesthesiologist satisfaction will also be noted during spinal anaesthesia positioning by using the scale mentioned . Pinprick assessments will be noted at 2, 4, 8, 10, 15, and 20 minutes, while total surgery duration and time to the first analgesic requirement will also be assessed.
The onset of analgesia will be assessed as the absence of pinprick sensation in the front area of the thigh following the peripheral nerve block , after which the NRS pain score will also be evaluated. Perioperative patient comfort during positioning using the NRS scale for pain, with 0 representing the minimal pain level and 10 indicating the lowest pain level.
Complications including nausea, vomiting, hypotension, bradycardia , hematoma, and toxicity from local anaesthetic will be diligently observed.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
ASA I and II
Patient undergoing elective and emergency Neck of Femur Fracture |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Allergy to Local Anesthetics and Opioids
Local infection at site of block
Severe Cardiopulmonary disease
Bleeding Disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Pain During Positioning
easier and Faster Spinal Anesthesia Administration
Better Hemodynamic Stability
Decreased opioid and Sedative requirement
Delayed and reduced post-operative Analgesia needs
Higher patient Satisfaction
Potential Reduction in Complications |
Time interval based evaluation 2minutes,4minutes,8minutes,10minutes,15minutes,20minutes
Pain Score
Sensory Block(Pin prick Test)
Motor Block(Quadriceps Weakness)
Positioning Tolerance
Hemodynamic Paramaters
Additional Analgesia Needed
Complications Observed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to perform spinal anesthesia after block.
Within 5minutes
Within 10 minutes
Within 15 minutes
Patient comfort & satisfaction during positioning.
Anaesthesiologist’s satisfaction during positioning.
Hemodynamic stability during positioning & spinal anesthesia.
Incidence of block-related complications (nausea, vomiting, hypotension, bradycardia, hematoma, LAST).
Time to first postoperative analgesic requirement.
|
Recording the time if any of the above events occur |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="6"
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 aims to compare the effectiveness of ultrasound guided suprainguinal fascia iliac compartment block(SIFICB) with ultrasound guided femoral nerve block combined with lateral femoral cutaneous nerve block (FNB+LFCNB) for facilitating patient positioning prior to spinal anesthesia in patients with fracture femur. fracture femur patients usually experience severe pain,which makes positioning for spinal anesthesia difficult and uncomfortable. peripheral nerve blocks provide effective analgesia, reduce patient distress and allow smoother positioning for neuraxial anesthesia.the suprainguinal fascia iliac compartment block is believed to provide wider spread of local aesthetic and better analgesia compared to individual nerve blocks this prospective randomised comparative study will be conducted in 60 patients aged 18-7- years belonging to ASA physical status I and II undergoing surgery for fracture femur under spinal anesthesia. patients will be randomly divided into two groups of 30 patients each. Group- A Patients receive ultrasound guided suprainguinal fascia iliac compartment block with ropivacaine and dexamethasone. Group B Patients receive Ultrasound Guided femoral nerve block and lateral femoral cutaneous nerve block with ropivacaine and dexamethasone Pain during positioning will be assessed using Numerical Rating Scale (NRS) . additional parameters such as time taken to perform spinal anesthesia, patient comfort,anesthesiologist satisfaction,hemodynamic stability and duration of analgesia will also be evaluated. this study is expected to determine the more effective regional block technique for providing analgesia and improving positioning for spinal anesthesia in fracture femur patients, hereby improving preoperative patient comfort and overall anesthesia management |