| CTRI Number |
CTRI/2025/11/097845 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two types of nerve blocks to make patients more comfortable while positioning them for spinal anaesthesia during hip surgeries |
|
Scientific Title of Study
|
Comparison Of Peri Capsular Nerve Group Block Versus Supra Inguinal Fascia Iliaca Block For Positioning During Spinal Anaesthesia for Hip Surgeries – A Prospective Randomised Double Blinded Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek M Halli |
| Designation |
Junior Resident |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology
MEGAN Teaching District Hospital
Shimoga Institute of Medical Sciences
Shivamogga
Shimoga
KARNATAKA
577201
India |
| Phone |
9482045307 |
| Fax |
|
| Email |
abhishekhalli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashodha V |
| Designation |
Assistant Professor |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology
MEGAN Teaching District Hospital
Shimoga Institute of Medical Sciences
Shivamogga
Shimoga
KARNATAKA
577201
India |
| Phone |
9901632497 |
| Fax |
|
| Email |
yashdvg12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek M Halli |
| Designation |
Junior Resident |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology
MEGAN Teaching District Hospital
Shimoga Institute of Medical Sciences
Shivamogga
KARNATAKA
577201
India |
| Phone |
9482045307 |
| Fax |
|
| Email |
abhishekhalli@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhishek M Halli |
| Address |
Department of Anesthesiology
MEGAN Teaching District Hospital
Shimoga Institute of Medical Sciences
Shivamogga |
| 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 Abhishek M Halli |
McGann Teaching District Hospital, Shimoga Institute Of Medical Sciences |
Department of Anesthesiology
McGann Teaching District hospital
Shimoga Institute of Medical Sciences
Shivamogga
Shimoga
KARNATAKA |
9482045307
abhishekhalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supra Inguinal Fascia Iliaca Block and Pericapsular Nerve Group Block |
In this trial we are comparing the efficacy of both the blocks as to which block provides superior analgesia and better comfort during Spinal positioning and postoperative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study and give written consent for study
Patients undergoing elective and emergency Hip surgeries under spinal anesthesia
Age group of 18 – 70 years of either sex American society of anaesthesiologist (ASA) physical status I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of drug allergies
Patient who do not fit in age or ASA I/ II criteria
History of Bleeding disorders
Patients with Spine deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of Positioning Score |
30 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Analgesia |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhishekhhalli1413@gmail.com].
- For how long will this data be available start date provided 01-05-2026 and end date provided 01-05-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - contact with the above mentioned Email
|
|
Brief Summary
|
This prospective, randomized, double-blinded clinical study compares the Pericapsular Nerve Group (PENG) block with the Supra-inguinal Fascia Iliaca (SIFI) block for facilitating patient positioning during spinal anesthesia in hip surgeries. Hip fracture patients often experience severe pain, making spinal positioning difficult; thus, effective pre-spinal analgesia is essential.
A total of 84 adult patients (ASA I–II, aged 18–70 years) undergoing elective or emergency hip surgeries are randomized into two groups
Group P (PENG block) – 20 ml 0.25% levobupivacaine + dexamethasone
Group S (SIFI block) – same drug and volume, different technique
Blocks are performed under ultrasound guidance. After 30 minutes, patients are evaluated for
Primary Outcome Ease of Spinal Positioning (EOSP) Score (0–3 scale)
Secondary Outcomes
Pain scores (NRS) at rest and on movement
Amount of rescue fentanyl required
Operator (anesthesiologist) satisfaction
Quality and duration of postoperative analgesia
Complications (e.g., nausea, quadriceps weakness)
Patients are then positioned for spinal anesthesia, and postoperative analgesia is monitored for 24 hours.
The study aims to determine which block provides superior analgesia, better positioning comfort, and improved anesthesiologist convenience, potentially enhancing the overall safety and efficiency of spinal anesthesia in hip surgeries. |