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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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