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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  
Name  Address 
NIL   NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharma.bhavya17@gmail.com].

  6. 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.

  7. 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.

 
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