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CTRI Number  CTRI/2023/05/052732 [Registered on: 17/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
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 two blocks in patients going for Spinal anaesthesia for analgesia and positioning for Spinal anaesthesia.  
Scientific Title of Study   comparison of USG guided pericapsular nerve group block and fascia iliaca compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Susheela Taxak 
Designation  Senior professor  
Affiliation  Pt.B.D.Sharma,PGIMS, Rohtak 
Address  Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS, Rohtak
1561/J, Medical campus. Rohtak, Haryana
Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  susheelataxak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Susheela Taxak 
Designation  Senior professor  
Affiliation  PGIMS ROHTAK  
Address  Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS, Rohtak
1561/J, Medical campus. Rohtak, Haryana
Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  susheelataxak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Upasana  
Designation  Junior resident  
Affiliation  PGIMS ROHTAK  
Address  A 901, A block, Suncity Heights, lahdout road, Rohtak

Rohtak
HARYANA
124001
India 
Phone  7015149969   
Fax    
Email  upasna.seth.us@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS, Rohtak 
 
Primary Sponsor  
Name  PGIMS ROHTAK  
Address  Department of Anaesthesiology, Modular OT 2nd floor, Room no.206,Pt.B.D.Sharma,PGIMS, Rohtak 
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 
Susheela Taxak  PGIMS Rohtak  Department of Anaesthesiology, Modular OT, 2nd floor,Pt.B.D.Sharma,PGIMS, Rohtak
Rohtak
HARYANA 
9896067416

susheelataxak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comparison of USG guided pericapsular nerve group block and fascia iliaca compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries   VAS score will be recorded and Quality of positioning for spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  ASA 1-3 scheduled for hip surgeries
 
 
ExclusionCriteria 
Details  Any bleeding tendency and on anticoagulant therapy
• Peripheral neuropathy, allergy to amide local anaesthetics
• Mental disorders, local infection at injection site
• Patients who can sit comfortably or received analgesia 8 hrs prior to surgery
• Patients who refuse to participate in study will be excluded 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VAS score will be recorded
Quality of positioning for spinal anaesthesia 
Vas score
Before block
5min after block
10min after block
20min after block
30min after block 
 
Secondary Outcome  
Outcome  TimePoints 
post operative analgesia (VAS Score)  1 hour
4 hour
8 hour 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   25/05/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   It is the “Comparison of USG guided pericapsular nerve group block and fascia iliaca compartment block for positioning and analgesia prior to spinal anaesthesia in hip fracture surgeries.
Patients will be assessed based on VAS score and positioning during spinal anaesthesia.
 
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