| CTRI Number |
CTRI/2026/03/105599 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Patient came to hospital for upper limp surgeries and we used brachial plexus block using ultrasound guided retro clavicular approach using levobupivacaine and comparing dexmedetomidine and dexamethasone as adjuvants to it. |
|
Scientific Title of Study
|
Comparative Study Between Dexmedetomidine Versus Dexamethasone As An Adjuvant To Levobupivacaine In Ultrasound Guided Retro clavicular 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 |
Saloni Sharma |
| Designation |
PG 1st year resident |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesiology Mahatma Gandhi Medical College and Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8890431942 |
| Fax |
|
| Email |
salonisharma09057@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Hospital and medical college Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department Of Anaesthesiology Mahatma Gandhi Medical College And Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi hospital jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesiology Mahatma Gandhi Medical College And Hospital Sitapura Jaipur Rajasthan India 302002 |
| 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 Saloni Sharma |
Mahatma Gandhi Medical College And Hospital |
Department Of Anaesthesia 2nd floor OT complex Sitapura Jaipur 302002 Jaipur Rajasthan
Jaipur
RAJASTHAN |
8890431942
salonisharma09057@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee Mahatma gandhi medical college and hospital jaipur Mahatma gandhi university of medical science and technology jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Dexamethasone |
inj Levobupivacaine 0.5:% 18 ml+ inj Dexamethasone 8 mg ( 2ml )=20ml
|
| Intervention |
Injection dexmedetomidine |
inj Levobupivacaine 0.5 % 18 ml + inj Dexmedetomedine
( 0.3 ml+1.7ml saline )=20ml
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for upper limb surgeries where ultrasound guided
retroclavicular brachial plexus block is to be given
Age 18-65yrs
All genders
ASA grade 1 or 2
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare onset and duration of sensory and motor block between the groups |
Motor blockade scale at 0,5,10,15,20,25,30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare -
Postoperative VAS score
Haemodynamic parameters (HR,SBP,DBP,MAP)
The time to requirement of first rescue analgesia
Postoperative complications if any
|
0 minutes, 30 minutes, 1 hour, 2 hour, 3 hour,6 hour, 12 hour |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Although general anesthesia continues to be choice of anesthesia for most of the surgical procedures, regional anesthesia has been increasing in popularity because regional anesthesia techniques can be utilized for analgesia not only during, but during the post operative period as well. This is a Comparative study between Dexmedetomidine versus Dexamethasone as an adjuvant to Levobupivacaine in ultrasound guided Retroclavicular Brachial plexus block in patients undergoing upper limb surgeries. Total sample size of 70 patients which is divided into two equal groups |