| CTRI Number |
CTRI/2026/03/105232 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two pain-relief injections to find out which one helps hip surgery patients sit comfortably while receiving spinal anesthesia. |
|
Scientific Title of Study
|
STUDY ON PERICAPSULAR NERVE GROUP VS SUPRAINGUINAL FASCIA ILIACA BLOCK FOR SPINAL ANAESTHESIA POSITIONING IN HIP 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 |
RAMYA M |
| Designation |
Post Graduate |
| Affiliation |
Indira Gandhi Government General Hospital and Post Graduate Institute, Puducherry. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE
Victor Simonel Street White Town, PUDUCHERRY.
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8883218541 |
| Fax |
|
| Email |
ramyaneyveli1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. NIDHI SRIVASTAVA M.D. |
| Designation |
SPECIALIST GR-I |
| Affiliation |
Indira Gandhi Government General Hospital and Post Graduate Institute, Puducherry. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE
Victor Simonel Street White Town, PUDUCHERRY.
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8489901978 |
| Fax |
|
| Email |
drnidhi33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAMYA M |
| Designation |
Post Graduate |
| Affiliation |
Indira Gandhi Government General Hospital and Post Graduate Institute, Puducherry. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE
Victor Simonel Street White Town, PUDUCHERRY.
Pondicherry
PONDICHERRY
605001
India |
| Phone |
8883218541 |
| Fax |
|
| Email |
ramyaneyveli1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE, PUDUCHERRY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE,
Victor Simonel Street, White Town, PUDUCHERRY. |
| Type of Sponsor |
Other [Government 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 |
| RAMYA M |
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE, PUDUCHERRY |
DEPARTMENT OF ANAESTHESIOLOGY
INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POST GRADUATE INSTITUTE,
Victor Simonel Street, White Town, PUDUCHERRY.
Pondicherry
PONDICHERRY |
08883218541
ramyaneyveli1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pericapsular Nerve Group Block |
Ultrasound guided Block with 20ml of 0.25% injection bupivacaine.The pericapsular nerve group block which blocks the articular branches supplying hip joint (the femoral nerve, articular branches of femoral nerve , obturator and the accessory obturator nerve) has known to be effective mode of analgesia in hip fracture patients. |
| Intervention |
Suprainguinal Fascia Iliaca block |
Ultrasound guided Block with 20ml of 0.25% injection bupivacaine.In fascia iliaca block ,the proximal branches of the lateral femoral cutaneous nerve has been spared leading to inconsistent blockade .This is overcome by the supra inguinal approach superior to the inguinal ligament blocking both the femoral and lateral femoral cutaneous nerve completely. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 to 80 years of age
Both genders
ASA physical status 1, 2 and 3.
Patients posted for elective hip surgeries
|
|
| ExclusionCriteria |
|
|
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 degree of analgesia using VAS score at rest and at 15 degree limb elevation between PENG and SIFI block in patients undergoing hip surgeries
To assess the ease of spinal position score [EOSP]
|
18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic changes: Pulse rate, Systolic blood pressure, diastolic blood pressure and mean arterial pressure and Oxygen saturation. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/03/2026 |
| 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 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
|
The aim of the study is to compare the efficacy of Ultrasound guided Pericapsular Nerve Group Block with Suprainguinal Fascia Iliaca block in patient positioning during spinal anaesthesia in patients with hip fractures |