| CTRI Number |
CTRI/2026/04/107588 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact of adding Dexamethasone to Bupivacaine in ultrasound Guided infraclavicular Block for upper limb surgeries |
|
Scientific Title of Study
|
A Comparative Study Of USG Guided Infra Clavicular Block Using
BUPIVACAINE Alone And BUPIVACAINE With DEXAMETHASONE In 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 Mayurkumar Gopalbhai Sorathiya |
| Designation |
Second Year Resident Doctor |
| Affiliation |
B.J. medical college,Ahmedabad |
| Address |
Department of Anethesiology, B.J. Medical College Ahemdabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9904695733 |
| Fax |
|
| Email |
MAYURSORATHIYA4@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Bhaarat Maheshwari |
| Designation |
Associate Professor |
| Affiliation |
B.J. medical college,Ahmedabad |
| Address |
Department of Anethesiology, B.J. Medical College Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824030419 |
| Fax |
|
| Email |
DRBHAARAT@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR Bhaarat Maheshwari |
| Designation |
Associate Professor |
| Affiliation |
B.J. medical college,Ahmedabad |
| Address |
Department of Anethesiology, B.J. Medical College Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824030419 |
| Fax |
|
| Email |
DRBHAARAT@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Government of Gujarat health and family welfare department 7TH Floor new Sachivalaya Ghandhinagar 382010 Gujarat INDIA |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Government of Gujarat health and family welfare department 7TH Floor new Sachivalaya Ghandhinagar 382010 Gujarat INDIA |
| Type of Sponsor |
Government 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 Mayurkumar Gopalbhai Sorathiya |
Orthopedic Surgery Department |
Orthopedic Operation theatre Trauma building civil hospital Campus Asarwa Ahmedabad
Ahmadabad
GUJARAT |
9904695733
MAYURSORATHIYA4@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICAL COMMITTE B.J. MEDICAL COLLEGE & CIVIL HOSPITAL AHMEDABAD |
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 |
| Intervention |
inj. BUPIVACAINE 0.5 % 18ml + inj. DEXAMETHASONE 2ml |
USG Guided infra Clavicular block using BUPIVACAINE with DEXAMETHASONE in upper limb surgeries. |
| Comparator Agent |
Inj. BUPIVACAINE 18ml +
Inj. NORMAL SALINE 2ml |
USG Guided infra Clavicular block using BUPIVACAINE in upper limb surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I, II, III.
2. Patient undergoing hand, wrist, elbow, and distal arm surgery
3. Duration of surgery: around two to three hours.
4. Elective surgery |
|
| ExclusionCriteria |
| Details |
1.Patients refusing to give consent
2.Local infection/inflammation.
3.Patients having coagulopathy and patient on anticoagulants
Patients having polytrauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia and To assess the time to first request of rescue analgesia in both groups |
To compare the duration of postoperative analgesia and To assess the time to first request of rescue analgesia in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess intraoperative & postoperative hemodynamic parameters |
15 minutes 30 minutes 45 minutes 60 minutes 90 minutes 120 minutes 150 minutes 180 minutes 4 hours 8 hours 12 hours 16 hours 20 hours 24 hours |
| To evaluate the incidence of adverse effects & complications |
15 minutes 30 minutes 45 minutes 60 minutes 90 minutes 120 minutes 150 minutes 180 minutes 4 hours 8 hours 12 hours 16 hours 20 hours 24 hours |
|
|
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)
|
17/04/2026 |
| 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 Yet Recruiting |
| 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
|
addition of dexamethasone to bupivacaine in ultrasound-guided infraclavicular brachial plexus block provides superior postoperative analgesia without compromising hemodynamic stability or safety. |