FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070565 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare the efficacy of pericapsular nerve group (PENG) block and infraclavicular fascia iliaca compartment block (FICB) for pain relief pre-operatively and post-operatively in patients posted for hip fracture surgery  
Scientific Title of Study   A RANDOMISED CONTROLLED STUDY TO COMPARE ANALGESIC EFFICACY OF PERICAPSULAR NERVE GROUP (PENG) BLOCK AND INFRAINGUINAL FASCIA ILIACA  
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 Aashish Manghrani 
Designation  Post Graduate Student 
Affiliation  Jawahar lal nehru medical college and hospital,AJMER 
Address  PAC ROOM 16, Department of anaesthesia,Jawahar lal nehru medical college and hospital,AJMER

Ajmer
RAJASTHAN
305001
India 
Phone  9414707652  
Fax    
Email  amanghrani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Mathur 
Designation  Professor 
Affiliation  Jawahar lal nehru medical college and hospital,AJMER 
Address  Anesthesia consultant room, Department of anaesthesia,Jawahar lal nehru medical college and hospital,AJMER

Ajmer
RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Mathur 
Designation  Professor 
Affiliation  Jawahar lal nehru medical college and hospital,AJMER 
Address  Anesthesia consultant room, Department of anaesthesia,Jawahar lal nehru medical college and hospital,AJMER

Ajmer
RAJASTHAN
305001
India 
Phone  9414003933  
Fax    
Email  drpoojarawat@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru, Medical College and Hospital, Ajmer, Rajasthan, India 3050001 Rajasthan ,India 
 
Primary Sponsor  
Name  Jawahar Lal Nehru medical college and Hospital 
Address  Jawahar Lal Nehru medical college and Hospital, Ajmer, Rajasthan, India 305001  
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 Aashish Manghrani  Jawahar Lal Nehru medical college and Hospital  Department of anaesthesiology Ortho ot 1st floor Jawahar Lal Nehru medical college and Hospital Ajmer Rajashthan
Ajmer
RAJASTHAN 		 09414707652

amanghrani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee ,Jawahar Lal Nehru medical college and Hospital Ajmer Rajashthan  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 
Comparator Agent  Fascia Iliaca Compartment Block [FICB]   analgesic efficacy during positioning for spinal anaesthesia is checked after 30 minutes of block application in patients with hip surgeries and post operative analgesia for 24 hours using Ultrasound guided FICB block 
Intervention  Perivascular Nerve Group [PENG] Block  Analgesic efficacy during positioning for spinal anaesthesia is checked after 30 minutes of block application in patients with hip surgeries and post operative analgesia for 24 hours using Ultrasound guided PENG block  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA PS 1-4
Baseline pain score associated with hip fractures more than or equal to 4 
 
ExclusionCriteria 
Details  Patients who do not agree to participate in this study
Patients with uncontrolled hypertension, hyperthyroidism, severe dementia
Allergic to bupivacaine
Contraindicated to spinal anaesthesia
Patientwho are considered ineligible with any other reason by investigators 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
In terms of analgesic efficacy during positioning (sitting) for spinal
anaesthesia in patients with hip fracture. 		 Pre operatively
30 minutes after block application 
 
Secondary Outcome  
Outcome  TimePoints 
To compare post operative analgesic efficacy.
To compare postoperative analgesic consumption in 24 hours
postoperative period.
To compare postoperative motor function of quadriceps femoris
To assess & compare hemodynamic changes if any 		 perioperatively at 5min,20min, 35min, 50min till surgery ends & post operatively at 2hours, 6 hours, 12hours, 18hours, 24hours 
 
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/ Phase 4 
Date of First Enrollment (India)   23/07/2024 
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
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 25-09-2023 and end date provided 31-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   With the progressively aging population, hip fracture has become a significant public health issue worldwide. Peripheral nerve block provides as good-quality analgesia as epidural anesthesia, and it is superior to systemic opioids for pain relief.
The primary aim of the study is to compare Pericapsular nerve group block (PENG) and Fascia iliaca compartment block (FICB) . In terms of analgesic efficacy during positioning (sitting) for spinal anaesthesia in patients with hip fracture.
 It will also compare post operative analgesic efficacy, postoperative analgesic consumption in 24 hours, postoperative motor function of quadriceps femoris and hemodynamic changes if any.
 
Close