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CTRI Number  CTRI/2023/11/059548 [Registered on: 06/11/2023] Trial Registered Prospectively
Last Modified On: 05/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effectiveness of ultrasound guided pericapsular nerve group block and Femoral nerve block for patient positioning during spinal anaesthesia in patients undergoing hip surgeries  
Scientific Title of Study   Comparison of pre operative ultrasound guided pericapsular nerve group [PENG]block versus femoral nerve block for optimal patient positioning during spinal anaesthesia in patients undergoing hip surgeries - a randomized concurrent parallel study. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Logesh R 
Designation  1st year post graduate  
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of anesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9500730980  
Fax    
Email  logesh.ravichandran@avmc.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr E Shanmugavalli 
Designation  Associate professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of anesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9940882722  
Fax    
Email  vallijegan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Suresh rajkumar 
Designation  Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of anesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9894723687  
Fax    
Email  bommidisrk@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam Pondicherry Pondicherry PONDICHERRY 607402 India  
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital 
Address  Aarupadai veedu medical college and hospital Kirumampakkam Pondicherry cuddalore highway Pondicherry 
Type of Sponsor  Private 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 Logesh R  Aarupadai veedu medical college and hospital  Department of Anaesthesiology First floor A block Kirumampakkam Cuddalore pondicherry highway Pondicherry
Pondicherry
PONDICHERRY 		 9500730980

logesh.ravichandran@avmc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethical committee aarupadai veedu medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine   0.5% Bupivacaine 10ml diluted to 20ml of 0.25% Bupivacaine. 
Intervention  Femoral nerve block  Patient undergoing hip fracture surgeries will be given preoperative ultrasound guided femoral nerve block with 20ml of 0.25% bupivacaine and assesed for VAS pain score and other outcomes 
Intervention  Pericapsular nerve group block  Patient undergoing hip fracture surgeries will be given preoperative ultrasound guided pericapsular nerve group block with 20ml of 0.25% bupivacaine and assesed for VAS pain score and other outcomes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA-Physical status I II and III
Patients undergoing hip surgeries
Neck of femur fracture
Intertrochanteric fracture
peri trochanteric fracture)
 
 
ExclusionCriteria 
Details  Patient refusal
Known allergy to local anaesthetics
Hemodynamically unstable patients
Bleeding disorder
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate PENG block and Femoral nerve block for optimal patient positioning
during spinal anaesthesia by means of analgesic efficacy (VAS score) and assistants required. 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for spinal anaesthesia  30min 
Post operative analgesia requirement in first 24 hours  24 hours 
Early mobilization  24 hours 
Complication of PENG and Femoral nerve block   24 hours 
Patient satisfaction score  24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/11/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hip fractures are more common in Orthopedics surgeries. Positioning of those patients for spinal anaesthesia for surgeries is a difficult task since patient will have severe pain. Am doing a comparative study of pericapsular nerve group block and femoral nerve block for patient positioning for spinal anaesthesia and the effectiveness of both block and  post operative analgesia. 
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