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CTRI Number  CTRI/2024/08/072388 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 11/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ultrasound guided dual subsartorial block versus ACB + IPACK for postoperative recovery profile after total knee replacement 
Scientific Title of Study   Ultrasound guided dual subsartorial block versus combined adductor canal block and interspace between popliteal artery and capsule of knee (IPACK) block for postoperative recovery profile after total knee arthroplasty 
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 Bhumika Sharma 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9958120682  
Fax    
Email  bhumi150296@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kohli 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9818073402  
Fax    
Email  dramitkohli@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kohli 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, Delhi, 110002

Central
DELHI
110002
India 
Phone  9818073402  
Fax    
Email  dramitkohli@yahoo.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, metro station central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi 110002, India  
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, 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 
Dr Bhumika Sharma  Lok Nayak Hospital  OT Block, Lok Nayak Hospital, near Delhi Gate, New Delhi, Delhi 110002
Central
DELHI 		 9958120682

bhumi150296@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics 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 
Comparator Agent  adductor canal block plus IPACK block  ultrasound guided proximal adductor canal block plus interspace between popliteal artery and capsule of knee block using 0.2% Ropivacaine 
Intervention  dual subsartorial block  ultrasound guided distal femoral triangle block plus proximal adductor canal block using 0.2% Ropivacaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA physical status I, II & III undergoing unilateral total knee arthroplasty. 
 
ExclusionCriteria 
Details  1. Any contraindication to spinal anaesthesia.
2. Infection at the site of block injection.
3. Any known history of allergy to local anaesthetics.
4. Patients on opioids for chronic pain.
5. Pregnancy and lactating women. 
 
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 
mean duration of postoperative analgesia  time at which first rescue analgesia will be given
(variable for each patient) 
 
Secondary Outcome  
Outcome  TimePoints 
mean time by TUG test  24 hours
48 hours 
MRC score for evaluation of postoperative quadriceps muscle strength  6 hours
12 hours
24 hours
48 hours 
mean total opioid consumption in first 24 hour of the block  24 hours 
Percentage of people experiencing postoperative pain at site 1, 2a, 2b, 2c, 2d, 3 according to appendix II  time to first rescue analgesia 
mean time to postoperative ambulation  time to postoperative ambulation 
mean patient satisfaction score by Likert scale  24 hours
48 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/08/2024 
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 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   We are comparing two techniques of combined peripheral nerve blocks for postoperative recovery profile in patients who had undergone unilateral total knee arthroplasty. Block will be administered just after the completion of the surgery. We will be evaluating various parameters like duration of analgesia, pain scores, additional opioid consumption ,quadriceps muscle strength. 
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