| CTRI Number |
CTRI/2026/03/106409 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Compare The Effectiveness Of Dexmedetomidine And Fentanyl By Adding To Levobupivacaine In Patients Undergoing Hand Surgeries |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Dexmedetomidine And Fentanyl As Adjuvant To Levobupivacaine 0.5% In Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries - A Randomised Clinical Trial |
| 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 Asfaque Alam |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anesthesiology Regional Institute of Medical Sciences Imphal
Imphal West MANIPUR 795004 India |
| Phone |
8768479820 |
| Fax |
|
| Email |
asfaquealam007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yumnam Arunkumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anesthesiology Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
| Phone |
9862282518 |
| Fax |
|
| Email |
yaks48@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yumnam Arunkumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anesthesiology Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
| Phone |
9862282518 |
| Fax |
|
| Email |
yaks48@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Department of Anesthesiology Regional Institute of Medical Sciences Imphal West Manipur 795004 |
| 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 Asfaque Alam |
Regional Institute of Medical Sciences Imphal |
Department of Anesthesiology Regional Institute of Medical Sciences Imphal Imphal West MANIPUR |
08768479820
asfaquealam007@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 |
| Intervention |
ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERIES |
| Comparator Agent |
ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERIES WITH DEXMEDETOMIDINE AS ADJUVANT TO LEVOBUPIVACAINE
|
Patients will receive 19 mL of 0.5% levobupivacaine+ 0.5mcg/kg dexmedetomidine diluted in 1 mL of normal saline (total 20 mL) |
| Comparator Agent |
ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERIES WITH FENTANYL AS ADJUVANT TO LEVOBUPIVACAINE
|
Patients will receive19 mL of 0.5% levobupivacaine+ 0.5mcg/kg fentanyl diluted in 1 mL of normal saline (total 20 mL). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II scheduled for elective upper limb surgeies |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Local site infections
3.Patients on anticoagulants or bleeding disorders
4.Hypersensitivity to amide group of Local anaesthetic agents and dexmedetomidine.
5.Pre-existing neuropathy or neurological disorders of upper limb autonomic neuropathy /peripheral nerve injury
6.Significant cardiac, hepatic or renal disease
7.Pregnancy and lactation |
|
|
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 |
| To compare the onset and duration of sensory and motor block between dexmedetomidine and fentanyl as adjuvants to levobupivacaine in ultrasound-guided supraclavicular brachial plexus block |
BASELINE, 15 MINUTES,30 MINUTES, 45 MINUTES, 60 MINUTES, 90 MINUTES, 120 MINUTES, 2 HOURS, 4 HOURS,6 HOURS, 8 HOURS, 10 HOURS & 12 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare duration of post operative analgesia between the two groups. |
BASELINE, 15 MINUTES,30 MINUTES, 45 MINUTES, 60 MINUTES, 90 MINUTES, 120 MINUTES, 2 HOURS, 4 HOURS,6 HOURS, 8 HOURS, 10 HOURS & 12 HOURS |
To compare the adverse effects like bradycardia, tachycardia, hypotension,
anaphylaxis, nausea or vomiting between the two groups.
|
BASELINE, 15 MINUTES,30 MINUTES, 45 MINUTES, 60 MINUTES, 90 MINUTES, 120 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
13/04/2026 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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, reduced side- effects, and shortened stay in the 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. Levobupivacaine with lesser cardiac side effects is the preferred local anaesthetic agent. Dexmedetomidine and Fentanyl is used to reduce the onset time, prolong the analgesic, and motor blockade effect without the systemic side effects and reduce total dose of local anesthetic requirement. Here, in our study we determine the onset and duration of analgesia and compare the hemodynamic parameters with two different drugs of Dexmedetomidine and Fentanyl with 0.5% Levobupivacaine. We also try to find any adverse reaction to the study drugs. A total of 100 patients undergoing upper limb surgeries will be divided into two groups: Group A and Group B by block randomization. Group A will receive 19 ml of 0.5% Levobupivacaine with 1 ml of 0.5mcg/kg Dexmedetomidine and Group B will receive 19 ml of 0.5% Levobupivacaine with 1 ml of 0.5mcg/kg Fentanyl. Duration of analgesia, onset of sensory and motor block, 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 depicted whenever possible, statistically analysed and inference will be drawn. | |