| CTRI Number |
CTRI/2026/01/102167 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Ways of Giving Dexamethasone with a Local Anaesthetic Injection to Reduce Pain After forearm Surgery |
|
Scientific Title of Study
|
perineural or intravenous dexamethasone as an adjunct to ropivacaine for prevention of rebound pain in ultrasound guided supraclavicular block a randomized placebo control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT medical college |
| Address |
Emergency OT, Department of Anaesthesia
RNT Medical College Udaipur Rajasthan
RNT medical college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09829025373 |
| Fax |
|
| Email |
Vbedimd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College |
| Address |
Emergency OT ,Department Of Anaesthesia
RNT Medical College Udaipur Rajasthan
RNT Medical College Udaipur Rajasthan
RAJASTHAN
313001
India |
| Phone |
09829025373 |
| Fax |
|
| Email |
Vbedimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Bedi |
| Designation |
Senior Professor |
| Affiliation |
RNT Medical College |
| Address |
Emergency OT Department Of Anaesthesia RNT Medical College Udaipur
RNT Medical College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09829025373 |
| Fax |
|
| Email |
Vbedimd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MB Government Hospital Rnt Medical College Udaipur |
| Address |
Department of Anaesthesia , MB Government Hospital RNT Medical College Udaipur Rajasthan 313001 |
| 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 Ayesha Siddiqui |
MB Government Hospital Udaipur |
Orthopedics Operation Theatre, 2nd Floor Trauma Center , MB Government Hospital RNT Medical College Udaipur Rajasthan
Udaipur
RAJASTHAN |
9026883710
miss.ayeshaaa@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: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj dexamethasone 16mg |
inj dexamethasone 16 mg will be administered intravenously alongwith usg guided supraclavicular brachial plexus block with 20cc ropivacaine 0.5% with 2cc normal saline The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
| Comparator Agent |
injection dexamethasone 8mg |
injection dexamethasone2cc 8mg with 20cc ropivacaine 0.5% to total volume of 22ml will be administered in usg guided supraclavicular block. The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
| Comparator Agent |
placebo group normal saline 0.9% |
2cc normal saline will be administered perinerually via usg supraclavicular brachial plexus block using 0.5% ropivacaine alonwith 10ml normal saline administered intravevously The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
| Intervention |
USG guided brachial plexus block |
The effectivity of prevention of rebound pain will be assessed with perineurally administered dexamethasone 8mg with 20cc of 0.5 % ropivacaine under usg guided supraclavicular block compared with the other group receiving brachial plexus block wih 0.5% ropivacaine with 16mg dexamethasone intravenously and other group which will receive 20ccc 0.5% ropivacaine with 2cc normal saline perineurally alongwith 10ml normal saline as placebo. The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
all consenting adults age 18-80 years ASA 1 AND 2 category of either gender undergoing open reduction and internal fixation of fracture forearm boe under brachial plexus block |
|
| ExclusionCriteria |
| Details |
patients already on steroid therapy
patients with diabetes mellitus
patients allergic to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the proportion of patients experiencing rebound pain defined as a score of more than or equal to 7 on visual assessment scale in the first 48 hours |
the proportion of patients experiencing rebound pain defined as a score of more than or equal to 7 on visual assessment scale in the first 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the time of occurrence of first episode of rebound pain |
The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
| The Visual Analogue Scale Score of 0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
0,1,2,4,8,24 ,36,48 hours postoperatively will he assessed |
| the cumulative tramadol consumption in the first 24 hours |
First 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/02/2026 |
| 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 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
|
my thesis topic is perineural or intravenous dexamethasone as an adjunct to ropivacaine in supraclavicular brachial plexus block for prevention of rebound pain a randomised placebo control trial . kindle give CTRI approval |