| CTRI Number |
CTRI/2025/12/098364 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Dexmedetomidine and dexamethasone in supraclavicular block for upper arm surgery |
|
Scientific Title of Study
|
Comparison Between Dexamethasone And Dexmedetomidine As A Perineural Adjuvant In Supraclavicular Brachial Plexus Block |
| 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 Neha Kumari |
| Designation |
Postgraduate Resident |
| Affiliation |
Peoples College Of Medical Sciences Bhopal |
| Address |
Room no 1 1st floor Peoples Hospital Bhanpur Ayodhya Bypass Road Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9630557125 |
| Fax |
|
| Email |
Dr.nehayadav687@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Agarwal |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Peoples College Of Medical Sciences and Research Centre Bhopal |
| Address |
Room no 1 Department of Anaesthesiology Poeples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Agarwal |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Peoples College Of Medical Sciences and Research Centre Bhopal |
| Address |
Room no 1 Department of Anaesthesiology Poeples Hospital Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8989147838 |
| Fax |
|
| Email |
akankshaagarwal2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Bhanpur Bhopal Madhya Pradesh India 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital Bhanpur Bhopal |
| Address |
Ayodhya Bypass Road Bhopal Madhya Pradesh 462037 |
| 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 Neha Kumari |
Peoples Hospital |
Room no 1 1st floor Department of Anaesthesiology PCMS and RC Bhanpur Bhopal
Bhopal
MADHYA PRADESH |
9630557125
Dr.nehayadav687@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College Of Medical Sciences And Research Centre By Pass Road Bhanpur Bhopal 462037 M P 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 |
| Intervention |
Dexemethasone |
Patient will receive Injection Dexamethasone 4mg diluted with Normal Saline upto 5ml with Injection 0.5 percent bupivacaine hydrochloride 15ml with inj lignocaine with adrenaline 10ml |
| Comparator Agent |
Dexmedetomidine |
Patient will receive Inj Dexmedetomidine 50 mcg diluted with Normal Saline upto 5ml with Injection 0.5 percent bupivacaine hydrochloride 15ml with injection lignocaine with adrenaline 10ml and observed for sensory and motor block effect for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight 50-80 kilograms
ASA grade I and II
All patients scheduled for elective upper limb surgeries under supraclavicular brachial plexus block |
|
| ExclusionCriteria |
| Details |
Patient refusal for consent
Age less than 18 years and more than 60 years
ASA grade III and IV
Patients with abnormal coagulation profile
Patients with local skin site infections
Patient allergic to study drugs
Pregnant and lactating mothers
Failure or inadaequate supraclavivular block patient will be excluded |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of Dexmedetomidine and Dexamethasone as a perineural adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block. |
UPTO 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the onset time and duration of sensory and motor blockade of Dexmedetomidine with 0.5% Bupivacaine for Supraclavicular brachial plexus block.
To assess the onset time and duration of sensory and motor blockade of Dexamethasone with 0.5% Bupivacaine for Supraclavicular brachial plexus block.
To observe time required for Rescue Analgesia in both the groups.
To compare the observations of the 2 groups.
|
upto 6 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/12/2025 |
| 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="1"
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
|
As per the Allocated days for each groups, participants in Group A will receive Injection Dexmedetomidine 50mcg diluted with Normal Saline upto 5ml with Injection 0.5 percent bupivacaine hydrochloride 15ml with Injection lignocaine with adrenaline 10ml, and those in Group B will receive Injection Dexamethasone 4mg diluted with Normal Saline upto 5ml with Injection 0.5 percent bupivacaine hydrochloride 15ml with injection lignocaine with adrenaline 10ml. Supraclavicular block will be given using landmark technique to the patients using drugs as per group under all aseptic precautions. Completion of injection will be considered as time 0 After completion of injection vital parameters will be noted. Onset of sensory and motor blockade, duration of sensory and motor blockade will be assessed. Sensory and motor blockade evaluation will be done every 2 min until complete sensory and motor block or till 30 min, whichever will be earlier. VAS scoring will be done post operatively every 1.5 hours till 6 hours.
|