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CTRI Number  CTRI/2025/08/092163 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Dexmedetomidine used as an adjuvant with ropivacaine for ultrasound guided supraclavicular brachial plexus block for Upper limb surgery  
Scientific Title of Study   Comparative Evaluation of Dexmeditomidine as an Adjuvant to 0.5% Ropivacaine in Supraclavicular Brachial Plexus Block for Upper Limb Surgeries : A Randomized Double Blind Controlled Interventional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karan Swami 
Designation  Postgraduate student Anaesthesiolgy 
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia,Maharana Bhopal Government Hospital,RNT Medical college,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9991909947  
Fax    
Email  karanswami0099@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Karan Swami 
Designation  Postgraduate student Anaesthesia 
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia,RNT Medical college,Udaipur
Department of Anaesthesia,RNT Medical college,Udaipur
Udaipur
RAJASTHAN
313001
India 
Phone  9991909947  
Fax    
Email  karanswami0099@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karan Swami 
Designation  Postgraduate student Anaesthesiolgy 
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia,Maharana Bhopal Government Hospital,RNT Medical college,Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9991909947  
Fax    
Email  karanswami0099@gmail.com  
 
Source of Monetary or Material Support  
RNT Medical College,Udaipur 
 
Primary Sponsor  
Name  RNT Medical College 
Address  RNT Medical College,Udaipur,Rajasthan,Pin code-313001 
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 
Karan Swami  RNT Medical College  Department of Orthopaedics ,RNT Medical College,Near Court Circle,Udaipur,Pin Code-313001
Udaipur
RAJASTHAN 
9991909947

karanswami0099@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT Medical College and Controller and Attached Hospitals,Udaipur  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  Regional Anaesthesia  Ultrasound Guided Supraclavicular Brachial Plexus Block 
Comparator Agent  Ropivacaine , Dexmeditomidine  Ropivacaine 0.5 percent alone,Ropivacaine 0.5 percent with 50 microgram Dexmedetomidine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologists physical status I-II
2.Upper limb surgeries below mid humerus level of duration 1-2 hours
3.Body Weight -40-70kgs
4.Subject Willing to Give Written and Informed Consent 
 
ExclusionCriteria 
Details  1.Uncooperative Patients.
2. Infection at the site of injection.
3. History of allergy to the study drugs.
4. Bleeding disorder and coagulopathies.
5. History of convulsions, severe neurological deficits 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia in the both groups.  Duration of Analgesia is the time postoperatively when patient will demand for rescue analgesia or when patient NRS score is equal to or more then 4 in first 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To Study Onset sensory block in both groups.
 
Immediately after block in minutes 
To study onset of motor block in both groups.  Immediately after block in minutes 
To compare Duration of sensory in both groups.  Assessed postoperatively in first 24 hours 
To compare Duration of Motor block in both groups.  Assessed Postoperatively in first 24 hours 
To study Hemodynamic Response in both groups.  Assessed in first 24 hours after block. 
To study side effects and complications if any in both groups   Assessed in first 24 hours after block. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   11/08/2025 
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="0"
Months="3"
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  

The aim of giving anaesthesia to patients is performing safe and painless surgical and other medical procedures. 

The upper extremity peripheral nerve blocks have been extensively used by anaesthetists for upper limb surgeries for decades. The peripheral nerve blocks have several benefits like better pain control, less undesirable side effects, and reduced hospital stay over general anaesthesia, thus providing a superior outcome. In peripheral nerve blocks, injection of the regional anaesthetic is given in the close vicinity of a specific nerve or bundle of nerves to block pain sensation generated and transmitted from a specific area of the body The local anaesthetic drugs block the transmission of pain signals from surgical site to the brain. Longacting local anaesthetic agents like bupivacaine and ropivacaine have been routinely used for upper limb surgeries in supraclavicular brachial plexus block. Ropivacaine is frequently used because it produces quick, dense, and prolonged block and has lesser side effects.

Due to the possibility of the effect of the local anaesthetic wearing out before the surgical period and causing severe pain, the volume of the local anaesthetic drug has been increased but it is associated with systemic side effects, particularly on the cardiovascular and nervous system. Therefore, several drugs such as opioids, nonsteroidal anti-inflammatory drugs NSAIDs, Alpha2-agonists, etc have been researched as adjunct agents to local anaesthetics. These are termed as analgesic 

adjuvants. They increase the efficacy and duration of local anaesthetics and decrease the systemic side effects of a higher dose of local anaesthetic. However, the adjuvant itself may exhibit its own side effects such as hypotension, sedation, bradycardia, etc. 

Dexmedetomidine is an Alpha 2 -adrenoreceptor agonist that has sedative, anxiolytic, and analgesic properties. Various studies have reported prolonged block and better postoperative analgesia with the administration of dexmedetomidine as an adjuvant to other local anaesthetics like bupivacaine or levobupivacaine. 

However, there is very limited literature available on dexmedetomidine in combination with ropivacaine and the optimal dose of dexmedetomidine as an adjuvant in nerve blocks is still to be determined. 

Furthermore, in clinical practice, none of the adjuvants is approved by the FDA. The use of such agents is completely off-label and depends on the assessment of risk to benefit ratio by the anaesthesiologists. Therefore, the debate regarding the advantages and disadvantages of using such an agents is a continuous topic discussion in the medical fraternity. 

For this reason and with this background in mind, the present study will be designed with the aim for comparative evaluation of dexmedetomidine as an adjuvant to 0.5 percent ropivacaine in supraclavicular brachial plexus block for upper limb surgeries in terms of duration of analgesia, onset and duration of sensory and motor block, quality of block, duration of postoperative analgesia 

 
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