| CTRI Number |
CTRI/2026/03/106241 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexamethasone and dexmedetomidine as adjuvants in supraclavicular brachial plexus block |
|
Scientific Title of Study
|
Comparative study between Dexmedetomidine versus Dexamethasone as an adjuvant to Bupivacaine in ultrasound guided Supraclavicular Brachial plexus block in patients undergoing upper limb 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 Solanki Archanaben |
| Designation |
Postgraduate resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital OT complex Second floor Department of Anesthesia main hospital building RIICO Industrial Area Mahatma gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9119184172 |
| Fax |
|
| Email |
archanasolanki0311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munesh Meena |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital OT complex Second floor Department of Anesthesia main hospital building RIICO Industrial Area Mahatma gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
8696067975 |
| Fax |
|
| Email |
meena.munesh1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munesh Meena |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital OT complex Second floor Department of Anesthesia main hospital building RIICO Industrial Area Mahatma gandhi Road Sitapura Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
8696067975 |
| Fax |
|
| Email |
meena.munesh1983@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesia and Critical Care, Mahatma Gandhi Hospital Sitapura Jaipur Rajasthan, 302022, india |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archanaben Solanki |
Mahatma Gandhi Hospital |
OT complex Department of Anesthesia, Mahatma Gandhi hospital Sitapura,Jaipur Rajasthan India
Jaipur
RAJASTHAN |
09119184172
archanasolanki0311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone as an adjuvant to 0.5% bupivacaine in supraclavicular brachial plexus block in patients undergoing upper limb surgery. |
Dexamethasone (8 mg) will be used as an adjuvant to 0.5% bupivacaine (18 ml) for ultrasound-guided supraclavicular brachial plexus block in patients undergoing upper limb surgery |
| Intervention |
Dexmedetomidine |
Dexmedetomidine (50 µg) will be used as an adjuvant to 0.5% bupivacaine (18 ml) in ultrasound-guided supraclavicular brachial plexus block. The drug will be administered perineurally as a single dose at the time of block in patients undergoing upper limb surgery. |
| Comparator Agent |
Dexmedetomidine as an adjuvant to 0.5% bupivacaine in supraclavicular brachial plexus block in patients undergoing upper limb surgery. |
Dexmedetomidine (50 µg) will be used as an adjuvant to 0.5% bupivacaine (18 ml) for ultrasound-guided supraclavicular brachial plexus block in patients undergoing upper limb surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for upper limb surgery
patients of all genders
Patient aged between 18-65 years
patient with American society of anaesthesiologists (ASA) class I and II |
|
| ExclusionCriteria |
| Details |
Patient with history of drug allergy
patient with newly diagnosed coagulopathy
infection at the injection site
Pre-existing neurological deficits in the operative limb
Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset time of sensory and motor block following ultrasound-guided supraclavicular brachial plexus block. |
Sensory and motor block will be assessed every 2 minutes after administration of the block until complete block is achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory & motor block after ultrasound-guided supraclavicular brachial plexus block. |
From the time of complete sensory & motor block until full recovery of sensory & motor function, assessed postoperatively up to 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized comparative study aims to compare the efficacy of dexmedetomidine versus dexamethasone as adjuvants to 0.5% bupivacaine in ultrasound-guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. The study will compare the onset and duration of sensory and motor block, duration of postoperative analgesia, between the two groups to determine the better adjuvant. |