| CTRI Number |
CTRI/2026/04/108657 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two ways of giving Dexmedetomidine given around nerve versus through a vein for better pain relief with Bupivacaine in nerve block. |
|
Scientific Title of Study
|
Comparison of post operative analgesic efficacy of perineural dexmedetomidine and intravenous dexmedetomidine as an adjuvant to bupivacaine 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 Akash Yadav |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College & Safdarjung Hospital,H693 H6W,NH 48,near AIIMS Hospital,Ansari Nagar West,New Delhi,Delhi 110029.
South
DELHI
110028
India |
| Phone |
9149294419 |
| Fax |
|
| Email |
doctorakash2024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Chandra |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College & Safdarjung Hospital,H693 H6W,NH 48,near AIIMS Hospital,Ansari Nagar West,New Delhi,Delhi 110029.
South
DELHI
110028
India |
| Phone |
7291061045 |
| Fax |
|
| Email |
maheshhchandra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Chandra |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College & Safdarjung Hospital,H693 H6W,NH 48,near AIIMS Hospital,Ansari Nagar West,New Delhi,Delhi 110029.
South
DELHI
110028
India |
| Phone |
7291061045 |
| Fax |
|
| Email |
maheshhchandra@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College & Safdarjung Hospital,H693 H6W,NH 48 near AIIMS Hospital,Ansari Nagar West,New Delhi,Delhi 110029, |
| 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 Akash Yadav |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College & Safdarjung Hospital,H693 H6W ,NH48,near AIIMS Hospital,Ansari Nagar West,New Delhi,Delhi 110029.
South
DELHI |
9149294419
doctorakash2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supraclavicular brachial plexus block with perineural dexmedetomidine |
It is a procedural intervention in regional anaesthesia and is a peripheral nerve block.Supraclavicular brachial plexus block will be done under the ultrasound guidance,20 ml of 0.5 percent Bupivacaine and 0.5 mcg per kg of Dexmedetomidine will be injected perineurally.It is compared with another group supraclavicular brachial plexus block along with intravenous Dexmedetomidine |
| Comparator Agent |
Supraclavicular brachial plexus block with intravenous dexmedetomidine |
it is a procedural intervention in regional anaesthesia and is a peripheral nerve block.Supraclavicular brachial plexus block will be done under the ultrasound guidance,20 ml of 0.5 percent bupivacaine injected perineurally and 0.5 mcg per kg of dexmedetomidine diluted in 50 ml of normal saline will be administered intravenously over 30 minutes started immediately after the block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
This study will include adult aged 18 to 65 years with ASA physical status I and II ,undergoing elective upper limb surgery requiring a supraclavicular brachial plexus |
|
| ExclusionCriteria |
| Details |
1- History of allergy or adverse reaction to local anaesthetics
2-Pregnancy or lactation
3-Any contraindication to supraclavicular nerve block. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative analgesia
|
Time of assessment-0 hour ,1hour,2hours,4hours,6hours and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Total dose of rescue analgesia required in 24 hrs
2-Patient satisfaction:Patient satisfaction with pain management will be assessed using Likert scale at 24 hours postoperatively |
Time of assessment-after 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
30/04/2026 |
| 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="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
|
This prospective randomized comparative interventional study compares post operative analgesic efficacy of perineural dexmedetomidine and intravenous dexmedetomidine as an adjuvant to bupivacaine in supraclavicular brachial plexus block in elective upper limb surgeries.
The primary objective is to compare the duration of post operative analgesia using perineural dexmedetomidine and intravenous dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided supraclavicular brachial plexus block in elective upper limb surgeries assesed by the time to first rescue analgesia.The secondary objective is to assess the total dose of rescue analgesics required in 24 hours in both groups. |