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CTRI Number  CTRI/2025/08/092344 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of IPSB and PENG block for pain relief and recovery after hip surgery 
Scientific Title of Study   Comparison of the Iliopsoas space block with the pericapsular nerve group block for postoperative analgesia and early functional recovery in patients undergoing hip surgery : a randomised controlled 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  Dr. Nishita Gupta 
Designation  Post graduate 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology Room no. 413 BL Taneja Block Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  8685092324  
Fax    
Email  guptanishita11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhyanti Kerai 
Designation  Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Department of Anaesthesiology ROOM NO. 413 BL TANEJA BLOCK MAMC Campus New Delhi

Central
DELHI
110002
India 
Phone  9965827122  
Fax    
Email  drsukhi25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sukhyanti Kerai 
Designation  Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Department of Anaesthesiology ROOM NO. 413 BL TANEJA BLOCK MAMC Campus New Delhi

Central
DELHI
110002
India 
Phone  9965827122  
Fax    
Email  drsukhi25@gmail.com  
 
Source of Monetary or Material Support  
OT 2 Orthopaedics OT OT Block Lok Nayak Hospital Maulana Azad Medical College New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College  
Address  Maulana Azad Medical College 2 Bahadur Shah Zafar Marg New Delhi 110002 
Type of Sponsor  Government 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 Nishita Gupta  Lok Nayak Hospital  OT 2 Orthopaedics Block OT Block Lok Nayak Hospital Maulana Azad Medical College New Delhi 110002
Central
DELHI 		 08685092324

guptanishita11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Maulana Azad Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Iliopsoas space block  In this group patients will receive IPSB and after 20-30mins Spinal anaesthesia will be given . Then postoperative analgesia and functional recovery will be assessed in these patients. 
Comparator Agent  Pericapsular nerve group block  In this group, patients will receive PENG block and after 20-30 mins spinal anaesthesia will be given. Post operative analgesia and functional recovery will be assessed in these patients 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. ASA I,II,III
2. Patients with height between 150-180cm
3. Expected duration of surgery less than 3 hours 
 
ExclusionCriteria 
Details  1. Patients with multiple trauma
2. History of prior hip surgery
3. Patients with cognitive impairement and pyschiatric illness
4. Known allergy to local anaesthetic drugs used in the study
5. Infection at the site of nerve block 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean numerical rating scale
(NRS) for post operative analgesia at 6hrs after surgery 		 6 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Quadriceps weakness assessment
 		 0,2,4,12 and 24 hours after surgery 
Mean numerical rating scale (NRS ) scores (at rest and movement)  0,2,4,12 and 24 hrs after surgery 
Mean total analgesic consumption  24 hrs after surgery 
Mean time to passing of flatus for the first time   After surgery 
Mean PONV impact score   0,2,4,6,12 and 24 hrs after surgery 
Mean quality of recovery 15(QoR 15)  24 hrs after surgery 
Mean postoperative Pittsburgh sleep quality index (PSQI)  24hrs after surgery 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 4 
Date of First Enrollment (India)   18/08/2025 
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 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
  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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [guptanishita11@gmail.com].

  6. For how long will this data be available start date provided 31-07-2027 and end date provided 31-07-2036?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a randomized controlled trial comparing the Iliopsoas space block and Pericapsular nerve group block for postoperative analgesia and early functional recovery that will be conducted in orthopaedic adult patients undergoing hip surgery under spinal anesthesia.
The primary outcome measures mean NRS for postoperative analgesia at 6hrs after surgery.
the secondary outcomes will be postoperative quadriceps strength assessment, PONV impact score, Quality of recovery 15 score, Pittsburg sleep quality index . 
 
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