| CTRI Number |
CTRI/2026/04/107777 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF ULTRASOUND-GUIDED PENG BLOCK IN COMPARISON WITH INTRAVENOUS OPIOID (FENTANYL) ON PAIN DURING PATIENT POSITIONING FOR CENTRAL NEURAXIAL BLOCK IN HIP FRACTURE SURGERY . |
|
Scientific Title of Study
|
EFFECT OF ULTRASOUND-GUIDED PENG BLOCK VS INTRAVENOUS OPIOID (FENTANYL) ON PAIN DURING PATIENT POSITIONING FOR CENTRAL NEURAXIAL BLOCKADE IN HIP FRACTURE 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 |
Bhavya Sharma |
| Designation |
Resident Anaesthesia |
| Affiliation |
|
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala
Ambala
HARYANA
133207
India
Ambala HARYANA 133207 India |
| Phone |
7015215505 |
| Fax |
|
| Email |
sharma.bhavya17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sapna Bansal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala
Ambala
HARYANA
133207
India
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
hod.anaesthesia@mmumullana.org |
|
Details of Contact Person Public Query
|
| Name |
Sapna Bansal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala
Ambala
HARYANA
133207
India
Ambala HARYANA 133207 India |
| Phone |
8168381441 |
| Fax |
|
| Email |
hod.anaesthesia@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA , MMIMSR , MULLANA , AMBALA ,Haryana 133207 , India |
|
|
Primary Sponsor
|
| Name |
Dr Sapna Bansal Professor and HOD Department of Anaesthesiology |
| Address |
Department of Anaesthesia,MM Institute of Medical Sciences and Research Centre,Mullana,Ambala ,Haryana 133207 ,India
Ambala
|
| Type of Sponsor |
Private medical college |
|
|
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 BHAVYA SHARMA |
MM INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE , MULLANA , AMBALA |
DEPARTMENT OF ANASETHESIOLOGY SECOND FLOOR OLD BUILDING , MM INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE , MULLANA , AMBALA, HARYANA133207 Ambala HARYANA |
07015215505
sharma.bhavya17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, MMIMSR MULLANA, AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
posted for hip fracture surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of intravenous opioid (fentanyl) |
Group F- Patient will receive intravenous fentanyl(2mcg/kg) |
| Intervention |
Effect of USG guided PENG block |
Group P- Patient will receive USG guided PENG block
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 60 years that will be scheduled to undergo hip fracture surgery under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Contraindications for spinal anesthesia or PENG block (infection at injection site, low ejection fraction, coagulopathy etc.),
Dementia or similar cognitive function impairments that made participation in some components of the study inadequate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to analyse effect of Ultrasound-guided PENG block vs intravenous opioid (fentanyl) on pain during patient positioning for central neuraxial blockade in hip fracture surgery |
to analyse effect of Ultrasound-guided PENG block vs intravenous opioid (fentanyl) on pain during patient positioning for central neuraxial blockade in hip fracture surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the hemodynamic changes
|
a)Preoperatively
b)Before positioning for the central neuraxial blockade
c)During positioning for central neuraxial blockade
|
|
|
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 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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="2" 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 - 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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sharma.bhavya17@gmail.com].
- For how long will this data be available start date provided 25-02-2025 and end date provided 31-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Proximal femur fractures are common in the elderly and require early surgical fixation for optimal pain relief and recovery. Spinal anesthesia is widely preferred due to its simplicity and lower complication rates, but severe pain during positioning can make its administration difficult. Poorly controlled perioperative pain is associated with delirium, increased morbidity and mortality, and chronic pain, making effective analgesia a top priority.
While opioids such as fentanyl provide adequate pain relief, their adverse effects have encouraged the use of regional anesthesia techniques, including femoral nerve block (FNB) and fascia iliaca compartment block (FICB). Recently, the ultrasound-guided pericapsular nerve group (PENG) block has been introduced as a novel technique targeting the articular branches of the femoral, obturator, and accessory obturator nerves to provide focused hip analgesia.
Although early reports suggest that the PENG block is effective for fracture-related pain, positioning for neuraxial anesthesia, and postoperative pain control, evidence remains limited. This study aims to evaluate the effectiveness of ultrasound-guided PENG block for improving patient positioning and compare its analgesic efficacy with intravenous fentanyl in patients undergoing hip fracture surgery under neuraxial anesthesia. |