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CTRI Number  CTRI/2025/04/085626 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Adult patients undergoing ultrasonography guided block for upper limb surgeries, comparing Dexamethasone and Dexmedetomidine when added to local Anaesthetics in terms of effect of Anaesthesia and duration of postoperative pain relief.  
Scientific Title of Study   A Randomised double-blind controlled trial to compare the block efficacy and duration of post-operative analgesia between dexamethasone and dexmedetomidine as adjuvant to local anaesthesia in ultrasound-guided Supraclavicular brachial plexus block in patients undergoing upper limb orthopaedic surgeries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr LAKSHMISRAVYA KETHARI  
Designation  Junior Resident, Dept. of Anaesthesia  
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, SEVAGRAM, WARDHA  
Address  Room No:27,Department of Anaesthesia, Main Operation Theatre,Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra,India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  8332080680  
Fax    
Email  sravya@mgims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr SUCHETA TIDKE  
Designation  Head Of The Department, Dept. Of Anaesthesia  
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, SEVAGRAM, WARDHA  
Address  Department Of Anaesthesia, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  9850510019  
Fax    
Email  suchetatidke@mgims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr LAKSHMISRAVYA KETHARI  
Designation  Junior Resident, Department Of Anaesthesia  
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, SEVAGRAM, WARDHA  
Address  Room no:5 PG Hostel, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  8332080680  
Fax    
Email  sravya@mgims.ac.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Institute of Medical Sciences, Sevagram,Wardha,Maharashtra, India, Pincode 442102 
 
Primary Sponsor  
Name  Mahatma Gandhi Institute of Medical Sciences  
Address  Sevagram, Wardha, 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 Lakshmisravya kethari   MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES  Main Operation Theatre, First Floor, Mahatma Gandhi Institute Of Medical Sciences, Sevagram,Wardha,Maharashtra, India, Pincode 442102.
Wardha
MAHARASHTRA 		 8332080680

sravya@mgims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S52||Fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local anaesthetics with 50mcg dexmedetomidine   Supraclavicular brachial plexus block will be given to adult patients undergoing upper limb orthopaedic surgeries using Local anesthetics 13ml of 2% Lignocaine with adrenaline plus 15ml of 0.5% Bupivacaine plus 50mcg dexmedetomidine (0.5ml dexmed + 1.5 ml normal saline). 
Comparator Agent  Local anesthetics with 8mg Dexamethasone   Supraclavicular brachial plexus block will be given to adult patients undergoing upper limb orthopaedic surgeries using 13ml of 2% Lignocaine with adrenaline plus 15ml of 0.5% Bupivacaine plus 8mg dexamethasone(2ml). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American society of Anesthesiologists (ASA) physical status I/II patients
2. Patients aged 18 years and above
3. Patients weight more than 50Kg
4. Patients of both male and female gender
5. Patients scheduled for emergency, semi emergency or elective upper limb
orthopaedic (elbow, forearm and hand) surgery.
6. Patients willing to take part in the study.
7. Hemodynamically stable patient with Heart rate 60 to 85/min, MAP 60 to 75mmHg 
 
ExclusionCriteria 
Details  1. Patients refusing to voluntarily participate in the study
2. Patients less than 18 years of age
3. Pre-existing peripheral neuropathy of upper limb
4. Patients with Bleeding disorders
5. Patients with infection at injection site
6. Patients with pneumothorax
7. Patients on adrenoreceptor agonist or antagonist therapy
8. ASA III and above
9. Pregnancy
10. Known hypersensitivity to the study drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Onset and quality of sensory and motor block, Haemodynamic stability   3 hours 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   12/05/2025 
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-identiļ¬cation.

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sravya@mgims.ac.in].

  6. For how long will this data be available start date provided 05-06-2024 and end date provided 05-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is to compare the duration of postoperative analgesia and efficacy with two different adjuvants i.e. 8mg dexamethasone and  50mcg dexmedetomidine added to 2% lignocaine with adrenaline plus 0.5% bupivacaine in two different groups when used in adult patients undergoing ultrasonography guided supraclavicular brachial plexus block for upper limb orthopaedic surgeries. There is however paucity of data regarding dexamethasone and dexmedetomidine as adjuvants for local anaesthetics and therefore this study is planned to research the same.  
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