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CTRI Number  CTRI/2025/02/081088 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study where two adjuvent dexmedetomidine vs clonidine use with local anaesthetic agent in upper limb surgery. 
Scientific Title of Study   A comparative study of dexmedetomidine vs clonidine as an adjuvent to local anaesthetic drug in supraclavicular brachial plexus block. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paresh M Chaudhary 
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara
at-piparia,waghodiya
Vadodara
GUJARAT
391760
India 
Phone  09512305508  
Fax    
Email  chaudharyparesh2016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Shah 
Designation  Professor  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara
at-piparia,waghodiya
Vadodara
GUJARAT
391760
India 
Phone  09512305508  
Fax    
Email  nileshshah730@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nilesh Shah 
Designation  Professor  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara
at-piparia,waghodiya
Vadodara
GUJARAT
391760
India 
Phone  09512305508  
Fax    
Email  nileshshah730@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara Wagodhia , Pipariya, Vadodara Vadodara GUJARAT 391760 
Type of Sponsor  Private 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 
Paresh Chaudhary  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Wagodhia , Pipariya, Vadodara Wagodhia , Pipariya, Vadodara Vadodara GUJARAT 391760
Vadodara
GUJARAT 		 09512305508

chaudharyparesh2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE  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  Clonidine as an adjuvent to local anaesthetic 0.5mcg/kg  Clonidine as an adjuvent to local anaesthetic drug in supraclavicular brachial plexus block Dose: 0.5mcg/kg Frequency of route of administration:Single time with local anasthestic Total duration:14 hrs 
Intervention  Dexmedetomidine as an adjuvent to local anaesthetic 0.5mcg/kg  Dexmedetomidine as an adjuvent to local anaesthetic drug in supraclavicular brachial plexus block. Dose: 0.5mcg/kg Frequency of route of administration:Single time with local anasthestic Total duration:14 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient willing to sign inform consent.
ASA grade I and II patients posted for elective upper limb surgeries under
Supraclavicular Brachial Plexus Block 
 
ExclusionCriteria 
Details  Patient refusal
Infection at local site
Hypersensitivity or Allergy to local anaesthetic agent
Coagulation disorders
Patient on Anticoagulants
Alcoholic or patient with drug abuse
Patients receiving any drug that interact with our study drug
Pre Existing Nerve injury
Inadequate effect of nerve block or supplemented with other type of
anaesthesia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj Clonidine vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia  reversal of sensory and motor blockage and VAS score after giving blockage at following time point:
0 min
30 min
1 hr
2 hr
3 hr
4 hr
5 hr
7 hr
10 hr 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesia and haemodynamic responses to anaesthesia by having better outcome in haemodynamics  At end of surgery
up to 12 hrs after surgery 
 
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   N/A 
Date of First Enrollment (India)   01/03/2025 
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="6"
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 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 - 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 20-10-2024 and end date provided 20-10-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A COMPARATIVE OF DEXMEDETOMIDINE VS CLONIDINE AS AN  ADJUVANT TO LOCAL ANAESTHETIC DRUG IN SUPRACLAVICULAR  BRACHIAL PLEXUS BLOCK

OBJECTIVE:To observe and compare Onset and duration of sensory and motor block, To observe and compare Duration of analgesia,To compare Perioperative hemodynamic changes & any adverse effects


INCLUSION CRITERIA:
Patient willing to sign inform consent.

ASA grade I and II patients posted for elective upper limb surgeries under

Supraclavicular Brachial Plexus Block


Age: 18-65 years
EXCLUSION CRITERIA:Patient refusal
Infection at local site
Hypersensitivity or Allergy to local anaesthetic agent
Coagulation disorders
Patient on Anticoagulants
Alcoholic or patient with drug abuse
Patients receiving any drug that interact with our study drug
Pre Existing Nerve injury
Inadequate effect of nerve block or supplemented with other type of

anaesthesia


SAMPLE SIZE AND GROUP 

Group-1 :Patients who have received inj. Bupivacaine 0.5% 20 ml  with inj. Dexmedetomidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block.

Group-2: patients who have received inj. Bupivacaine 0.5% 20 ml with  inj. Clonidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block.


•Study site:  S.B.K.S. Medical Institute and Research Centre, Sumandeep Vidhyapeeth University, Piparia, Vadodara, Gujarat.

•Study duration: This study will be done for a periods of 18 months.


Study design:  comparative observational study


LIKELY OUTCOME / BENEFITS OF STUDY

 This prospective and observational study will help us to compare the efficacy between Inj.  Bupivacaine and Inj Clonidine vs Inj Bupivacaine and Inj dexmedetomidine Improving the  duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some  provide sedation haemodynamic responses to anaesthesia by having better outcome in  haemodynamics.






 
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