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CTRI Number  CTRI/2022/03/041349 [Registered on: 24/03/2022] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to Study The Effect Of Dexmedetomidine and Clonidine as an adjuvant to Bupivacaine 0.25% in supraclavicular brachial plexus block under ultrasound guidance 
Scientific Title of Study   Comparison of Dexmedetomidine and Clonidine as an adjuvant to Bupivacaine 0.25% in supraclavicular brachial plexus block under ultrasound guidance : A prospective randomised double blind study   
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yathish N 
Designation  ASST PROF 
Affiliation  SANJAY GANDHI INSTITUTE OF TRAUMA AND ORTHOPAEDICS 
Address  Sanjay gandhi institute of trauma and orthopedics, Byrasandra, Jayanagar east, Bangalore
Byrasandra, Jayanagar east, Bangalore
Bangalore
KARNATAKA
560011
India 
Phone  9964277476  
Fax    
Email  YATHISH_HONKAN@YAHOO.COM  
 
Details of Contact Person
Scientific Query  
Name  Yathish N 
Designation  ASST PROF 
Affiliation  SANJAY GANDHI INSTITUTE OF TRAUMA AND ORTHOPAEDICS 
Address  Sanjay gandhi institute of trauma and orthopedics, Byrasandra, Jayanagar east, Bangalore
Byrasandra, Jayanagar east, Bangalore
Bangalore
KARNATAKA
560011
India 
Phone  9964277476  
Fax    
Email  YATHISH_HONKAN@YAHOO.COM  
 
Details of Contact Person
Public Query  
Name  Yathish N 
Designation  ASST PROF 
Affiliation  SANJAY GANDHI INSTITUTE OF TRAUMA AND ORTHOPAEDICS 
Address  Sanjay gandhi institute of trauma and orthopedics, Byrasandra, Jayanagar east, Bangalore
Byrasandra, Jayanagar east, Bangalore
Bangalore
KARNATAKA
560011
India 
Phone  9964277476  
Fax    
Email  YATHISH_HONKAN@YAHOO.COM  
 
Source of Monetary or Material Support  
Sanjay gandhi institute of trauma and orthopaedics  
 
Primary Sponsor  
Name  sanjay gandhi institute of trauma and orthopaedics 
Address  Byrasandra, Jayanagar east, Bengaluru 
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 
Yathish N  sanjay gandhi institute of trauma and orthopedics  Department Of Anaesthesia/Operation Theatre
Bangalore
KARNATAKA 		 9964277476

YATHISH_HONKAN@YAHOO.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjay Gandhi Institute Of Trauma And Orthopaedics  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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: V871||Person injured in collision between other motor vehicle and two- or three-wheeled motor vehicle (traffic), (5) ICD-10 Condition: S529||Unspecified fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  Clonidine 100mcg added to 29 ml of 0.25% bupivacaine, single dose 
Intervention  Dexmedetomidine  Dexmedetomidine 100mcg added to 29ml of 0.25%bupivacaine,single dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status I and II patients of either sex
Aged between 18 to 65 years and normal BMI
Elective upper limb orthopaedic surgeries
 
 
ExclusionCriteria 
Details  Patients with severe medical comorbidities and local site infection
Patients receiving adrenoceptor agonist or antagonist therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study duration of analgesia and time to request of rescue analgesia in first 24hours post surgery
 		 first 30 minutes post surgery and then every 2nd hourly till patient requests for rescue analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
Time Of Onset And Duration Of Sensory And Motor Blockade and Any other Side Effects
 		 first 30 minutes after surgery and every 2nd hourly thereafter 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   15/04/2022 
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 Yet Recruiting 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 (Others) - 

  6. For how long will this data be available start date provided 22-02-2022 and end date provided 22-02-2027?
    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  
.Regional anesthesia is the most used procedure for upper limb surgeries.
•Ultrasound guided  supraclavicular approach for the brachial plexus block is preferred, as they produce ideal  operating conditions with fewer complications
•Apart from local anesthetic agents, multiple  other drugs were used as adjuvants.
•In the recent past, both dexmedetomidine and clonidine were extensively studied as an adjuvant agent.  
•Alpha 2A receptor specificity of dexmedetomidine over clonidine was quoted to be  one of the reasons for better efficacy over clonidine.
•In this study, we will compare dexmedetomidine with clonidine as an adjuvant in upper limb surgeries. 
 
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