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CTRI Number  CTRI/2022/11/047773 [Registered on: 29/11/2022] Trial Registered Prospectively
Last Modified On: 30/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison of two separate techniques of ultrasound guided fascial plane blocks in patients with hip fractures for ease of positioning while giving spinal block for the surgery and also to provide post operative pain relief. 
Scientific Title of Study   Comparison of ultrasound guided Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Block to facilitate positioning for Subarachnoid Block and for postoperative analgesia in patients with intertrochanteric femur fracture for proximal femur nailing. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonam Lhamu Monpa 
Designation  Post Graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no 415, B L Taneja Block, 4th Floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9971406571  
Fax    
Email  sonamlhamu017@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kirti Nath Saxena 
Designation  Director Professor and Head of Department 
Affiliation  Maulana Azad Medical College 
Address  Room no 415, B L Taneja Block, 4th Floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9968604215  
Fax    
Email  kirtinath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sonam Lhamu Monpa 
Designation  Post Graduate student 
Affiliation  Maulana Azad Medical College 
Address  Room no 415, B L Taneja Block, 4th Floor, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9971406571  
Fax    
Email  sonamlhamu017@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Maulana Azad Medical College and associated Lok Nayak Hospital 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  JLN 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 
Sonam Lhamu Monpa  Lok Nayak Hospital  Department of Anaesthesiology and intensive care, B L Taneja Block
Central
DELHI 		 9971406571

sonamlhamu017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  Pericapsular Nerve Group Block (PENG)  to facilitate ease of positioning for subarachnoid block and for postoperative analgesia the patients undergoing Proximal femur nailing for Intertrochanteric femur fracture will be given PENG block preoperatively. 
Comparator Agent  Suprainguinal Fascia Iliaca Block (SIFI)  to facilitate ease of positioning for subarachnoid block and for postoperative analgesia the patients undergoing Proximal femur nailing for Intertrochanteric femur fracture will be given SIFI block preoperatively. Edit || Delete  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Adults patient of age 18-80 years scheduled to undergo elective unilateral intertrochanteric femur fracture surgeries under subarachnoid block.
2.American Society of Anesthesiologists (ASA) physical status I, II and III.
3.Patients with preoperative Numerica Rating Scale (NRS)>4 at rest and on passive 15 degrees limb lifting. 
 
ExclusionCriteria 
Details  1.Unwilling to participate or lacked the capacity to give consent.
2.Coagulopathy
3.Infection at the site of injection.
4.Allergy to local anesthetics.
5.On opioid for chronic pain. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ease of spinal positioning (EOSP) score 30 mins after the block.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Numerica Rating Scale (NRS) scores pre block, 30 mins after the block and postoperatively for 24 hours.  12 months 
Requirement of additional postoperative analgesics in 24hours.  12 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/12/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  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 (Others) -  sonamlhamu017@gmail.com

  6. For how long will this data be available start date provided 17-07-2024 and end date provided 17-07-2027?
    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   We are comparing two ultrasound guided musculofascial block techniques- Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Block to facilitate positioning for subarachnoid block and for postoperative analgesia in patients with intertrochanteric femur fracture for proximal femur nailing in adult patients between the age group of 18 to 80 years of age. We will be using standard subarachnoid block for patients undergoing elective surgeries. The aim of the study is to compare the two blocks with regards to ease of spinal positioning for subarachnoid block, decrease in pain scores after the blocks and postoperatively for 24 hrs and requirement of additional analgesics postoperatively for 24 hrs. We will be recruiting a total of 30 patients, and they will be randomized into two groups- Group P (Pericapsular Nerve Group Block) and Group S (Suprainguinal Fascia Iliaca Block). The ease of spinal positioning (EOSP) score will be assessed before and 30 mins after the blocks, pain will be assessed using the Numeric Rating Scale pre block, 30 mins after the block, 2hrs, 4hrs, 8hrs,12hrs and 24hrs after the block. Time to first requirement of analgesics postoperatively and total requirement of additional postoperative analgesia will be noted. 
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