| CTRI Number |
CTRI/2026/03/106924 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain relief between two nerve blocks before giving spinal Anesthesia |
|
Scientific Title of Study
|
Comparison between pre-operative femoral nerve block and fascia iliaca compartment block for pain relief during shifting and positioning for regional anaesthesia in patients with hip fracture- A prospective randomized 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 |
Salma Sharon |
| Designation |
Junior Resident |
| Affiliation |
Chettinad hospital and reasearch institute |
| Address |
Department of Anesthesiology
1st floor, ICU
Chettinad hospital and reasearch institute
Chettinad health city
Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
7540030139 |
| Fax |
|
| Email |
salmasharon00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Balamurugan |
| Designation |
Professor |
| Affiliation |
Chettinad hospital and reasearch institute |
| Address |
Department of Anesthesiology
1st floor, ICU
Chettinad hospital and reasearch institute
Chettinad health city
Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9841544566 |
| Fax |
|
| Email |
drbala.srmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Salma Sharon |
| Designation |
Junior Resident |
| Affiliation |
Chettinad hospital and reasearch institute |
| Address |
Department of Anesthesiology
1st floor, ICU
Chettinad hospital and reasearch institute
Chettinad health city
Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
7540030139 |
| Fax |
|
| Email |
salmasharon00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CHRI |
| Address |
Chettinad hospital and research institute,
Chettinad health city,
Kelambakkam,
Chennai 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Salma Sharon |
Chettinad Hospital |
Department of Anesthesiology
1st floor, ICU
Chettinad Hospital and Research institute
Chettinad Health City
Kelambakkam
Chennai
Chennai
TAMIL NADU |
7540030139
salmasharon00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CARE IHEC-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia iliaca compartment block |
Fascia iliaca compartment block will be administered 30 minutes prior to shifting and positioning the patient for regional anesthesia. The procedure duration is approximately 5–10 minutes. The effect of the intervention will be assessed by measuring pain score during positioning for regional anesthesia, within approximately 30 minutes of block administration. |
| Comparator Agent |
Femoral nerve block |
Femoral nerve block will be administered 30 minutes prior to shifting and positioning the patient for regional anesthesia. The procedure duration is approximately 5–10 minutes. The effect of the intervention will be assessed by measuring pain score during positioning for regional anesthesia, within approximately 30 minutes of block administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2 and 3
Patients with hip fracture |
|
| ExclusionCriteria |
| Details |
Patient refusal for study
Known allergy to study drug
Infection or inflammation at the site
Significant coagulopathy
INR more than 1.5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief during shifting and positioning of the patient |
0 minutes
30 minutes
35 minutes
40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of patient positioning for regional Anesthesia
Patient satisfaction score |
40 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/04/2026 |
| 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="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
|
Pain is severe in patients with hip fracture Nerve blocks are better in comparison with oral or IV analgesics due to prolonged action and lesser side effects Femoral nerve block has faster onset and prolonged effect than fascia iliaca compartment block Fascia iliaca compartment block has relatively less motor blockade making it advantageous for preventing fall post op and early mobilisation |