| CTRI Number |
CTRI/2025/12/098755 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
publication on intravenous dexamethasone 8mg in prolonging supraclavicular nerve block using isobaric bupivacaine in upperlimb surgeries |
|
Scientific Title of Study
|
publication on intravenous dexamethasone in prolonging supraclavicular nerve block using isobaric bupivacaine in upperlimb 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 |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15, Department of anaesthesia,vinayaka mission medical college and hospital,salem
Salem
TAMIL NADU
636308
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15, Department of anaesthesia,vinayaka mission medical college and hospital,salem
TAMIL NADU
636308
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drkrishnappreya |
| Designation |
post graduate |
| Affiliation |
vinayaka mission medical college and hospital ,salem |
| Address |
Room no 15, Department of anaesthesia,vinayaka mission medical college and hospital,salem
TAMIL NADU
636016
India |
| Phone |
09487873738 |
| Fax |
|
| Email |
nimmu1335@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
vinayaka mission medical college and hospital salem |
| Address |
chinnaseeragapadi,salem 636308 tamilnadu |
| 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 |
| Drkrishnappreya |
Vinayaka Mission medical college and hospital salem |
Room no 15, Department of anaesthesia,vinayaka mission medical college and hospital,salem 636308
Salem
TAMIL NADU |
09487873738
nimmu1335@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee vinayaka mission kirupanandha variyar medical college and hospitals salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of intravenous dexamethasone in prolonging supraclavicular nerve block using isobaric bupivacaine in upperlimb surgeries |
subjects will receive 30ml Local anaesthetic mixture with 8mg (2ml) dexamethasone intravenously and the other group will receive 2ml normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• 1. ASA grade I and II.
• 2. Age between 18-60 years.
• 3. All elective upper limb surgeries below shoulder
|
|
| ExclusionCriteria |
| Details |
• Patient refusal.
• Age less than 18 and more than 60 years .
• ASA grade 3 and 4.
• Severe hepatic or renal failure
• Infection at the site of injection
• Patient with known allergy to LA drugs
• Patients on chronic use of corticosteroids
• Patients with coagulation abnormalities.
• Patients with respiratory compromise
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of intravenous dexamethasone on the onset and duration of sensory and motor blockade |
from zero hours of block till 24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic profile, the duration of analgesia and to study blood glucose level. |
from zero hours of block till 24 hours of surgery |
|
|
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)
|
23/12/2025 |
| 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="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
|
It is a randomized prospective study is to look after the efficacy of intravenous dexamethasone 8mg in prolonging supraclavicular nerve block using isobaric bupivacaine in upperlimb surgeries to look for prolongation of the block
|