| CTRI Number |
CTRI/2026/01/102408 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two medicines that is Dexmedetomidine and Midazolam added to local anaesthetic to make forearm surgeries more comforatble and pain free . |
|
Scientific Title of Study
|
A prospective,randomized,double blind study to compare between Dexmedetomidine and Midazolam as an adjuvant to Bupivacaine (0.5 percent) in ultrasound guided supraclavicular brachial plexus block for forearm 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 RAVI RAJSHEKHAR BALLURGI |
| Designation |
Resident Doctor |
| Affiliation |
Vilasrao Deshmukh Government Medical College,Latur |
| Address |
Department of Anaesthesiology, Surgical building,First Floor,Government Medical College,Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9503698766 |
| Fax |
|
| Email |
raviballurgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUREKHA VYANKATRAO MORE |
| Designation |
Assistant Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College,Latur |
| Address |
Department of Anaesthesiology, Surgical building,First Floor,Government Medical College,Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9422741346 |
| Fax |
|
| Email |
desurekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUREKHA VYANKATRAO MORE |
| Designation |
Assistant Professor |
| Affiliation |
Vilasrao Deshmukh Government Medical College,Latur |
| Address |
Department of Anaesthesiology, Surgical building,First Floor,Government Medical College,Latur.
Latur
MAHARASHTRA
413512
India |
| Phone |
9422741346 |
| Fax |
|
| Email |
desurekha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vilasrao Deshmukh Government Medical College,Latur, Maharashtra, India.
413512 |
|
|
Primary Sponsor
|
| Name |
Vilasrao Deshmukh Government Medical College, Latur |
| Address |
Near Rajasthan Vidyalaya,Gandhi Chowk, Latur, Maharashtra, India.413512. |
| 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 RAVI BALLURGI |
Vilasrao Deshmukh Government Medical College Latur |
Surgery Operation theatre, 1st Floor,Surgical building, VDGMC, Latur
Latur
MAHARASHTRA |
9503698766
raviballurgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VDGMC,Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S520||Fracture of upper end of ulna, (2) ICD-10 Condition: S518||Open wound of forearm, (3) ICD-10 Condition: S562||Injury of other flexor muscle, fascia and tendon at forearm level, (4) ICD-10 Condition: S621||Fracture of other and unspecifiedcarpal bone(s), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Adding Dexmedetomidine 1 microgram per kg body weight as an adjuvant to Bupivacain (0.5 percent) 15 ml as a single dose in ultrasound guided Supraclavicular brachial plexus block in forearm surgeries. |
| Comparator Agent |
MIDAZOLAM |
Adding Midazolam 50 microgram per kg body weight as an adjuvant to Bupivacain (0.5 percent) 15 ml as a single dose in ultrasound guided Supraclavicular brachial plexus block in forearm surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) physical status I or II,
Weight more than 40 kg,
Those willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal,
Study drug contraindicated or Contraindications to regional anaesthesia,
Patients with coagulation disorders,local Skin infection, those who are morbidly obese, hemodynamically unstable,
ASA Physical status more than II. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia. |
From Local Anesthetic administration to 2,4,6,8,10,12,18hours till complete recovery of anesthesia on all nerves and complete recovery of Motor function of the hand and the forearm. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of Analgesia |
from Local Anaesthetic administration to the onset of analgesia at 5,10,15,20 minutes. |
| Hemodynamic changes like Heart rate, Systolic blood pressure,Diastolic blood pressure, SPO2 |
From Local Anaesthetic Administration to 5,10,15,30,60 minutes and every half hourly thenafter |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="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
|
Regional Anaesthesia technique have gained significant popularity due to their numerous benefits over general anaesthesia and systemic analgesia. Supraclavicular brachial plexus block is amongst the regional ananesthesia technique used most commonly for upper limb surgeries. But to increase post operative analgesia and for post operative patient satisfaction , only Bupivacain is not sufficient. So many adjuvants were tried along with Bupivacain in supraclavicular brachial plexus block. In my study, I have compared effect of Dexmedetomidine and Midazolam as an adjuvant to Bupivacain 0.5 percent in ultrasound guided supraclavicular brachial plexus block for forearm surgeries. I have compared onset of analgesia, hemodynamic parameters and total duration of post operative analgesia in Dexmedetomidine group and in Midazolam group. |