| CTRI Number |
CTRI/2025/10/096703 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Two Doses of Dexmedetomidine as an Adjuvant to Ropivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block |
|
Scientific Title of Study
|
Comparison of efficacy of two doses of dexmedetomidine as adjuvant to ropivacaine in ultrasound guided supraclavicular brachial plexus block: A Randomised Clinical Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhamed Shakeel |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institutions of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur - 795004, India
Imphal West
MANIPUR
795004
India |
| Phone |
9048606029 |
| Fax |
|
| Email |
shakmd31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashem Jack Meitei |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur - 795004, India
Imphal West
MANIPUR
795004
India |
| Phone |
9774262996 |
| Fax |
|
| Email |
jack2k49@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashem Jack Meitei |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur - 795004, India
MANIPUR
795004
India |
| Phone |
9774262996 |
| Fax |
|
| Email |
jack2k49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Manipur,India.
Pincode:795004 |
|
|
Primary Sponsor
|
| Name |
Muhamed Shakeel |
| Address |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Type of Sponsor |
Other [SELF] |
|
|
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 Muhamed Shakeel |
Regional Institute of Medical Sciences, Imphal West, Manipur |
Elective surgery Operation theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Mediccal Sciences, Imphal West, Manipur.
Imphal West
MANIPUR |
9048606029
shakmd31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
| Comparator Agent |
Group A - 19ml of 0.5% ropivacaine + 0.5mcg/kg dexmedetomidine diluted in 1ml of Normal saline |
Study participants will be randomized into two groups. Comparator group receiving 19ml of 0.5% ropivacaine + 0.5mcg/kg dexmedetomidine diluted in 1 ml Normal saline before surgery. |
| Intervention |
Group B - 19ml of 0.5% ropivacaine + 1mcg/kg dexmedetomidine diluted in 1ml of normal saline |
Study participants will be randomized into two groups. Intervention group receiving 19ml of 0.5% ropivacaine + 1mcg/kg dexmedetomidine diluted in 1ml normal saline before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) American Society of Anaesthesiologist - Physical State (ASA - PS) grade I and II |
|
| ExclusionCriteria |
| Details |
1) Patients having hypertension, diabetes mellitus, neuropathy, perioheral nerve injury.
2) Pregnancy and lactation
3) Patient on anticoagulants or bleeding disorder.
4) Hypersensitivity to amide group of local anaesthetic agents.
5) Patient refusal to procedure. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor block (using hollmen scale and modified bromage scale) |
From injection of study drug till the time patient feels pain (sensory) and able to move upper limb (motor) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
From injection of study drug till pain complains of pain |
| Hemodynamic parameters like systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, peripheral oxygen saturation) |
From injection of study drug to upto 2 hours. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="0"
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 techniques have advantages including excellent pain control, side effects, and shortened stay in post anaesthesia care unit. Ultrasound guided regional blocks are considered safer with better success rates. Supraclavicular block has high efficacy for providing anaesthesia in upper limb surgeries. Ropivacaine with lesser cardiac side effects is the preferred local anaesthetic agent. Dexmedetomidine is used to reduce the onset time, prolong the analgesic and motor blockade effect without systemic side effects and reduce total dose of local anaesthetic requirement. Here, in our study we determine the duration of analgesia and compare the hemodynamic parameters with two different doses of dexmedetomidine with 0.5% ropivcaine. We also try to find any adverse reaction to the study drugs. A total of 60 patients undergoing upper limb surgeries will be divided into two groups - Group A and Group B by block randomisation. Group A will receive Ropivacaine 0.5% with 1ml of 0.5mcg/ kg dexmedetomidine and Group B will receive Ropivacaine 0.5% with 1ml of 1mcg/kg dexmedetomidine. Duration of analgesia, onset of sensory and motor blockade effect, time requirement of rescue analgesia will be studied. Hemodynamic parameters and adverse effects will be recorded. The findings and observations made during the entire study will be tabulated, graphically analysed and inference will be drawn. |