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CTRI Number  CTRI/2024/06/068619 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
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   A clinical trial to study on femur fracture patients the effects of two nerve blocks in ease of positioning during spinal anaesthesia 
Scientific Title of Study   Comparative Evaluation Of Fascia Iliaca Block Vs Pericapsular Nerve Block in providing pain relief for ease of positioning during spinal anaesthesia in proximal femur fracture surgeries- a randomized control 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 Usha Kumari 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia, IGMC Shimla 
Address  Department of Anaesthesiology, Indira Gandhi Medical College, Lakkar bazaar, Shimla Himachal Pradesh

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Kumari 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia, IGMC Shimla 
Address  Department of Anaesthesiology, Indira Gandhi Medical College, Lakkar bazaar, Shimla Himachal Pradesh


HIMACHAL PRADESH
171001
India 
Phone  9459301813  
Fax    
Email  chaudhary.ushaarvind@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tamanna Nada 
Designation  Junior resident 
Affiliation  Department of Anaesthesia,IGMC Shimla 
Address  Department of Anaesthesiology, Indira Gandhi Medical College, Lakkar bazaar, Shimla Himachal Pradesh

Shimla
HIMACHAL PRADESH
171001
India 
Phone  8826114630  
Fax    
Email  tamanna.nada@gmail.com  
 
Source of Monetary or Material Support  
Himachal Pradesh Government Indira Gandhi Medical College Shimla :171001 Himachal pradesh India 
 
Primary Sponsor  
Name  Indira Gandhi Medical college 
Address  Ridge Sanjauli road, Lakkar Bazaar, Shimla, Himachal pradesh 171001 
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 Usha Kumari  Indira Gandhi Medical college Shimla  Department of Anesthesia , IGMC, lakkar bazaar -171001, shimla , Himachal Pradesh
Shimla
HIMACHAL PRADESH 		 9459301813

chaudhary.ushaarvind@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,IGMC,Shimla  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 block before Spinal anesthesia for ease of spinal positioning   Patient is given Fascia iliaca block in the recovery room 30 minutes before giving Spinal anesthesia. Decrease in vas and ease of spinal positioning is noted. Post operative duration of Analgesia also noted. 
Intervention  Pericapsular Nerve group block before Spinal anesthesia for ease of spinal positioning   Patient is given Pericapsular Nerve group block in the recovery room 30 minutes before giving Spinal anesthesia. Decrease in vas and ease of spinal positioning is noted. Post operative duration of Analgesia also noted. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients who belong to ASA I,II,III physical status of age 25 to 75 year with proximal femur fracture posted for surgery under subarachanoid block 
 
ExclusionCriteria 
Details  Patients with known allergy to local anesthetic
Patient with history of coagulopathy or on anticoagulant and antiplatelet drugs
Patient with infection at site of block



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Visual analog scale score at 30 minutes after block  Baseline , 30 minutes after block 
 
Secondary Outcome  
Outcome  TimePoints 
1)To calculate ease of spinal positioning
2)To compare anaesthetist satisfaction among groups on 5 point likert scale
3)To record visual analog score post operatively at 12 , 24 hr
4)To compare time of first rescue analgesia in both groups
5) To calculate total rescue analgesic requirement in first 24 hours 		 At 30 minutes , 12 hours, 24 hours  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial
Modification(s)  		 Phase 4 
Date of First Enrollment (India)   20/06/2024 
Date of Study Completion (India) 01/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 (Others) -  If someone approaches.

  2. What additional supporting information will be shared?
    Response (Others) -  Published article
  3. Who will be able to view these files?
    Response - Anyone

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

  5. By what mechanism will data be made available?
    Response (Others) -  On request via e mail.

  6. For how long will this data be available start date provided 02-06-2024 and end date provided 02-06-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Evidence comparing the effects of the pericapsular nerve group(PENG) block and fascia iliaca compartment block (FICB) 
remains unclear.There are few studies which used FICB or PENG for preoperative pain relief and positioning.Further large‐scale and high‐quality RCTs are required to supplement the present 
findings.Therefore, we intend to conduct a prospective randomised study comparing FICB vs PENG block for pain relief and ease of positioning during spinal anaesthesia in patients of 
fracture proximal femur.
 
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