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CTRI Number  CTRI/2021/09/036159 [Registered on: 02/09/2021] Trial Registered Prospectively
Last Modified On: 01/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Comparative Study Between Dexmedetomidine 100 And Clonidine 150 As Adjuvant To Ropivacaine In Ultrasound Guided Adductor Canal Block For TKR Surgeries  
Scientific Title of Study   A Randomized Comparative Study Between Dexmedetomidine And Clonidine As Adjuvant To Ropivacaine In Ultrasound Guided Adductor Canal Block For TKR Surgeries  
Trial Acronym  TKR ACB  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharath Kumar K 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Institute of Trauma And Orthopedics 
Address  Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India 
Phone  9620422424  
Fax    
Email  drbharthkumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharath Kumar K 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Institute of Trauma and Orthopedics 
Address  Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India 
Phone  9620422424  
Fax    
Email  drbharthkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Kumar K 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Institute of Trauma And Orthopedics 
Address  Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru
Bangalore
KARNATAKA
560011
India 
Phone  9620422424  
Fax    
Email  drbharthkumar@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Institute of Trauma And Orthopedics 
 
Primary Sponsor  
Name  Sanjay Gandhi Institute Of Trauma And Orthopedics 
Address  Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar Bengaluru 560011 
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 Bharath Kumar K  Sanjay Gandhi Institute of Trauma and Orthopedics  Sanjay Gandhi Institute of Trauma and Orthopedics Byrasandra Jayanagar
Bangalore
KARNATAKA 		 9620422424

drbharathkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjay Gandhi Institute of Trauma and Orthopedics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  clonidine 150mcg  single dose during block. 
Comparator Agent  dexmedetomedine 100 mcg  single dose during block administration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA I to III patients of either sex.
2)Undergoing unilateral total knee replacement surgeries.
 
 
ExclusionCriteria 
Details  1)Patients with a history of allergy to local anesthetics.
2)Patients with history of mental dysfunction.
3)Patient refusal.
4)Morbid obesity, coagulopathy and significant cardiovascular, respiratory, renal, hepatic or metabolic disease or CNS disorders.
5)Infection at site of procedure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Onset of sensory block
2)Duration of sensory blockade
3)Total rescue analgesia consumption in the first 24hrs.
 		 1 day 
 
Secondary Outcome  
Outcome  TimePoints 
adverse reactions if any  24 hrs 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/09/2021 
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   nil 
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Data are available indefinitely at (Link to be included nil).

  6. For how long will this data be available start date provided 25-12-2021 and end date provided 01-01-2026?
    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  
•Lower limb surgeries can be performed under satisfactory anesthetic conditions using general, regional and peripheral nerve block anesthesia. Yet postoperative pain and anesthetic side effects remain a problem.
•The adductor canal block, being segmental in nature, can be expected to produce some advantages regarding hemodynamic stability and may be a viable alternative to other techniques.
•Adductor canal block involves the unilateral administration of local anesthetics to the nerves without intervening central nervous system.
•This procedure allows avoiding the use of poly pharmacy and also can be used as an alternative method in patients with unstable cardiovascular systems

Primary objectives:

•To compare efficacy of Clonidine  and Dexmedetomedine as adjuvant to 0.2% Ropivacaine in adductor canal block for knee arthroscopic surgeries, with respect to
• Onset of sensory block
• Duration of sensory blockade
• Total rescue analgesia consumption in the first 24hrs.

Secondary objectives

•Hemodynamic parameters 
• Adverse effects, if any.
• Cardiovascular or neurological complications if any
 
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