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CTRI Number  CTRI/2025/02/081248 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
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   Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Ropivacaine 0.5 Percentage In Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries: A Randomised Clinical Trial 
Scientific Title of Study   Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Ropivacaine 0.5 Percentage 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  Arivumadhi Sankar 
Designation  Post Graduate Trainee-1st year 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology, Regional institute of medical science,Imphal

Imphal West
MANIPUR
795004
India 
Phone  8667647189  
Fax    
Email  arivumadhisankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  L Pradipkumar Singh 
Designation  Professor  
Affiliation  Regional institute of medical sciences, Imphal West, Manipur  
Address  Department of Anaesthesiology, Regional institute of medical sciences, Imphal West, Manipur.

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  L Pradipkumar Singh 
Designation  Professor  
Affiliation  Regional institute of medical sciences, Imphal West, Manipur  
Address  Department of Anaesthesiology, Regional institute of medical sciences, Imphal West, Manipur.

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, India. 795004 
 
Primary Sponsor  
Name  Arivumadhi Sankar 
Address  Regional Institute of Medical Sciences, Imphal, Manipur 
Type of Sponsor  Other [Self] 
 
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 Arivumadhi Sankar   Regional Institute of Medical Sciences  Elective surgery operation theatre complex(OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur, India - 795004
Imphal West
MANIPUR 
8667647189

arivumadhisankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S424||Fracture of lower end of humerus, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5 percentage Ropivacaine and Dexamethasone  Study participants will be randomized into two groups. Intervention group receiving 0.5% ropivacaine with dexamethasone as adjuvant in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. 
Comparator Agent  0.5 percentage Ropivacaine and Dexmedetomidine  Study participants will be randomized into two groups. Comparator group receiving 0.5% ropivacaine with dexmedetomidine as adjuvant in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of age group 18 to 60 years.
2. Patients of American Society of Anaesthesiologists (ASA) physical status grade I or II. 
 
ExclusionCriteria 
Details  1. Patients with hypertension, diabetes mellitus, autonomic neuropathy, peripheral nerve injury
2. Pregnancy or lactation.
3. Patients on anticoagulants or bleeding disorders.
4. Patients with hypersensitivy to amide group of local anaesthetic agents and dexmedetomidine.
5. Uncooperative/unwilling patients.
6. Local site infection. 
 
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) using 0.5% Ropivacaine and dexmedetomidine as adjuvant  Baseline and time when patient complains of pain and can start moving his limbs 
 
Secondary Outcome  
Outcome  TimePoints 
Onset & duration of sensory & motor block (using HOLLMEN SCALE) using 0.5% ropivacaine & dexamethasone as adjuvant  Baseline & time taken for patient to feel pain & move limbs 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   08/03/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Regional anesthesia techniques have advantages including excellent pain control, reduced side- effects, and shortened stay in the post anesthesia 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 and Dexamethasone 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 duration of analgesia and compare the hemodynamic parameters with two different drugs of Dexmedetomidine and Dexamethasone with 0.5% Ropivacaine. We also try to find any adverse reaction to the study drugs. A total of 52 patients undergoing upper limb surgeries will be divided into two groups: Group A and Group B by block randomization. Group D will receive 20 ml of 0.5% Ropivacaine with 2 ml of 20 mcg Dexmedetomidine and Group X will receive 20 ml of 0.5% Ropivacaine with 2 ml of 8mg Dexamethasone. 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 analyzed and inference will be drawn.

 
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