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CTRI Number  CTRI/2024/04/065671 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 07/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Patient undergoing total knee replacement surgery for postoperative analgesia comparing 0.125% Bupivacaine and 0.2% Ropivacaine infusion for adductor canal block  
Scientific Title of Study   Prospective randomized double-blind study to compare 0.125% Bupivacaine and 0.2% Ropivacaine infusion for adductor canal block after Total knee Arthroplasty for postoperative analgesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSakshi Khatri 
Designation  Postgraduate 
Affiliation  D Y Patil School Of Medicine 
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  9049666609  
Fax    
Email  sakshi07sep@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMona Jadhav 
Designation  Associate Professor  
Affiliation  D Y Patil School Of Medicine 
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  9763847148  
Fax    
Email  monajadhav601@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMona Jadhav 
Designation  Associate Professor  
Affiliation  D Y Patil School Of Medicine 
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra


MAHARASHTRA
400706
India 
Phone  9763847148  
Fax    
Email  monajadhav601@hotmail.com  
 
Source of Monetary or Material Support  
D. Y. Patil University School of Medicine and Hospital, Nerul, Navi Mumbai Department of Anaesthesiology  
 
Primary Sponsor  
Name  D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai  
Address  A-Block Department of Anesthesia D Y Patil School of Medicine Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra  
Type of Sponsor  Research institution and hospital 
 
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 Sakshi Khatri  D. Y. Patil University School of Medicine and Hospital, Nerul, Navi Mumbai   A block Department of Anesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 
9049666609

sakshi07sep@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health research of Dr D Y Patil Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion of 0.125% Bupivacaine in adductor canal block  Dose - 0.125% Bupivacaine Route of Administration - catheter in adductor canal Duration - 2 days Rate - 7ml/hour 
Comparator Agent  Infusion of 0.2% Ropivacaine via adductor canal block  Dose - 0.2% Ropivacaine Route of Administration - catheter in adductor canal Duration - 2 days Rate - 7ml/hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  Patient undergoing TKR.
All the adult patients.
ASA grade I and II.
Patients giving consent for study.
 
 
ExclusionCriteria 
Details  Patients with coagulopathy.
Allergy to local anaesthetics.
Infection at the site of block.
 
 
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, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Analgesic efficacy (VAS score 1-10) ; 10 is the worst pain.
 
Analgesic efficacy (VAS score 1-10) ; 10 is the worst pain.
 
 
Secondary Outcome  
Outcome  TimePoints 
Total consumption of rescue analgesia  In 24 hour 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   20/04/2024 
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="2"
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [sakshi07sep@gmail.com].

  6. For how long will this data be available start date provided 03-02-2024 and end date provided 03-02-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION:- A pragmatic multimodal approach for adequate pain management and for early ambulation after knee arthroplasty requires adductor canal blocks (ACB) or other regional techniques. Choosing the right dose of local anesthetic agent (LA) in ACB for pain management in knee arthroplasty is an important patient-centric decision. Inadequate volume or concentration may lead to inadequate analgesia, increased opioid consumption, and related morbidity and delayed discharge.Ropivacaine has lower lipid solubility than Bupivacaine which is responsible for lower penetration into myelinated motor fibers and thus less motor blockade. In view of the reduced toxic potential, ropivacaine has a definite edge over bupivacaine in regional anesthetic techniques requiring large volumes of local anesthetic.

AIMS AND OBJECTIVES:- Aim of the study is to compare the analgesic efficacy of 0.125 % bupivacaine and 0.2% ropivacaine  infusion for adductor canal block after total knee arthroplasty.

Primary object: -1) Analgesic efficacy (VAS score1-10) at different time interval; 10 is the worst pain. Secondary objective – Total consumption of rescue analgesia

STUDY PROCEDURE: - A prospective double blind randomized and comparative study will be conducted after approval from Institutional Ethical Committee and with informed written consent, thirty-six patients of American Society of Anesthesiologists (ASA) class I or class II of either sex, adult, undergoing elective Total Knee Arthoplasty surgeries done under spinal will be recruited. Patient will be given spinal anaesthesia. As per height & weight 0.5 % bupivacaine will be given. At the end of the surgery Adductor Canal Block will be given under ultrasound guidance by a trained qualified person by using needle catheter set. After confirmation of proper deposition of drug at the correct site, catheter will be introduced and fixed as per standard guide catheter will be introduced and fixed as per standard guidelines. Patient will be receiving study drug as per GROUP A AND GROUP B.GROUP A: Receiving 0.125% of Bupivacaine Infusion @7ML/HR. GROUP B: Receiving 0.2% of Ropivacaine Infusion @7ML/HR. All patients will receive Inj Paracetamol 100 ml TDS as per surgical protocol.Patient will be monitored for vas score along with the quadriceps muscle strength at the interval of 0. 1,2,4,8,12 and 24 hrs postoperatively If VAS score is more than 5,infusion rate will be increased to 10 ml/hr, if still VAS score is high patient will receive Inj.Tramadol 1mg per Kg intravenously. Total doses of rescue analgesics and side effects like nausea , vomiting. bradycardia and hypotension will be noted.

Statistical analysis will be done by applying appropriate test. Both groups will be compared for VAS score, quadriceps muscle strength, total doses of rescue analgesics and side effects. With the time interval of Baseline, 1,2,4,6,8,12,24 HR of Intervals.


 
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