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CTRI Number  CTRI/2023/07/055386 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   COMPARING THE EFFECT OF PLAIN ROPIVACAINE 0.375% AND ROPIVACAINE WITH NALBUPHINE FOR ADDUCTOR CANAL BLOCK AS A MODE OF POSTOPERATIVE ANALGESIA IN UNILATERAL TOTAL KNEE REPLACEMENT  
Scientific Title of Study   “ADDUCTOR CANAL BLOCK FOR POSTOPERATIVE ANALGESIA AFTER SIMULTANEOUS UNILATERAL TOTAL KNEE REPLACEMENT; A COMPARATIVE EVALUATION OF NALBUPHINE AS AN ADJUVANT TO ROPIVACAINE” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSHANKRAPPA LAMANI 
Designation  Postgraduate Resident 
Affiliation  Chamarajanagar Institute of Medical Sciences  
Address  Chamarajanagar Institute of Medical Sciences,Chamarajanagar
‘C’ Quarters ,Doctors Block , Chamarajanagar
Chamarajanagar
KARNATAKA
571313
India 
Phone  8748074737  
Fax    
Email  shankarlamani1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDarshan M S  
Designation  HOD , Department of anaesthesiology  
Affiliation  Chamarajanagar institute of medical sciences  
Address  Chamarajanagar institute of medical sciences,Chamarajanagar
Department of anaesthesiology, Chamarajanagar institute of medical sciences
Chamarajanagar
KARNATAKA
571313
India 
Phone  9741376797  
Fax    
Email  darshanms_jss@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrSHANKRAPPA LAMANI 
Designation  Postgraduate Resident 
Affiliation  Chamarajanagar Institute of Medical Sciences  
Address  Chamarajanagar Institute of Medical Sciences,Chamarajanagar
Major OT Complex 4th Floor,New Hospital , Yadapura ,Chamarajanagar
Chamarajanagar
KARNATAKA
571313
India 
Phone  8748074737  
Fax    
Email  shankarlamani1996@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology Chamarajanagar institute of medical sciences,Chamarajanagar 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Chamarajanagar institute of medical sciences,Chamarajanagar  
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 
DrShankrappa lamani  Chamarajanagara Institute of Medical Sciences   Department of Anaesthesiology, Major OT complex , 4th Floor, Chamarajanagar Institute Of Medical Sciences , Yedapura , Chamarajanagar.
Chamarajanagar
KARNATAKA 		 8748074737

shankarlamani1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutational Ethical Committe , CIMS   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 
Intervention  Inj.Ropivacaine   19ml of 0.375% Inj. Ropivacaine with 1ml of Normal Saline In Adductor Canal Block as Single Dose 
Comparator Agent  Inj.Ropivacaine with Inj.Nalbuphine   19ml of 0.375% Inj. Ropivacaine with 1ml of 10mg Inj.Nalbuphine In Adductor Canal Block as Single Dose 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient scheduled for elective Total knee replacement surgery with American society of anaesthsiologist (ASA) physical status grade 1 and 2
2.patient willing to give informed consent
3.patient with Age between 35 to 65 years
 
 
ExclusionCriteria 
Details  1.patient with severe chronic obstructive pulmonary disease
2.Coagulation disorders
3.known allergy to any of the study drugs
4.Local infection
5.focal neurological deficit in lower limb  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the duration of postoperative analgesia after Adductor Canal Block performed.  In the Immediate Postoperative period  
 
Secondary Outcome  
Outcome  TimePoints 
Time of ambulation in two groups
Haemodynamic stability
Total analgesic requirement for next 12hours
Any side effects in postoperative Day 0 and 1

 		 Post op Day 0 and 1
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 16/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/02/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shankarlamani1996@gmail.com].

  6. For how long will this data be available start date provided 17-02-2025 and end date provided 18-02-2026?
    Response (Others) -  17-02-2025 and end date 18-02-2026

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Total knee replacement (TKR) is one of the commonly performed surgeries in modern orthopedics and agreeably associated with severe postoperative pain if untreated. The aim of anesthesia in such cases is to provide adequate analgesia without motor weakness so that early ambulation can be promoted and shorter hospital stay.

            Since ages combined spinal epidural anesthesia remained the mainstay for TKR. However epidural analgesia for postoperative analgesia has its own demerits such as catheter related issues and side effects of opioids. The use of systemic opioids and NSAIDs especially in elderly warranted.

            The recent success of adductor canal block (ACB)  in providing excellent postoperative analgesia, along with prospects of early ambulation is very promising. with the advent of ultrasonography (USG). adductor canal block can be administered with a high success rate. Adductor canal block has been used successfully used for postoperative analgesia.  Need for rescue analgesics in form of opioid can be significantly reduced.
The present study will be done to compare the duration of analgesia of adductor canal block using ropivacaine with nalbuphine as adjuvant after total knee replacement
 
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