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CTRI Number  CTRI/2025/08/092386 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
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   Incidence of increased Pain After Supra-clavicular Nerve Block Wears Off, With and Without Adding Dexmedetomidine  
Scientific Title of Study   INCIDENCE OF REBOUND PAIN WITH OR WITHOUT DEXMEDETOMIDINE AS AN ADJUVANT IN SUPRA-CLAVICULAR BLOCK - A RANDOMISED CONTROL 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 Prasanna Vadhanan 
Designation  HOD 
Affiliation  Vinayaka mission medical college and hospital 
Address  Room no 1 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post

Karaikal
PONDICHERRY
609609
India 
Phone  9486489690  
Fax    
Email  vadhanan.prasanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Kumar 
Designation  Junior resident/Post Graduate 
Affiliation  Vinayaka mission medical college and hospital 
Address  Room no 2 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post

Karaikal
PONDICHERRY
609609
India 
Phone  9955555120  
Fax    
Email  rkroy5577@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Kumar 
Designation  Junior resident/Post Graduate 
Affiliation  Vinayaka mission medical college and hospital 
Address  Room no 2 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post

Karaikal
PONDICHERRY
609609
India 
Phone  9955555120  
Fax    
Email  rkroy5577@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka mission medical college Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Karaikal Pondicherry 609609. 
 
Primary Sponsor  
Name  Vinayaka mission medical college 
Address  Keezhakasakudy Medu Kottucherry Puducherry 609609 
Type of Sponsor  Private 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 Rahul Kumar   Vinayaka mission medical college  Department of Anaesthesiology Keezhakasakudy Medu Kottucherry
Karaikal
PONDICHERRY 		 9955555120

rkroy5577@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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  Group A  Under USG Guidance, Supraclavicular Block given using Drug volume of total 30cc which contains mixture of Bupivacaine 0.5% 15cc, Lignocaine with Adrenaline 2% 10cc, Dexmedetomidine 1mcg per kg and remaining volume filled with distilled water 15 minutes before start of surgery. 
Comparator Agent  Group B  Under USG Guidance, Supraclavicular Block given using Drug volume of total 30cc which contains mixture of Bupivacaine 0.5% 15cc, Lignocaine with Adrenaline 2% 10cc and remaining 5ml distilled water 15 minutes before start of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Scheduled for elective surgeries (upper limb, upper thorax) requiring supra-clavicular block.
ASA physical status classification I or II.
Willingness to participate and provide informed consent. 
 
ExclusionCriteria 
Details  Contraindications to supra-clavicular block.
Allergy or intolerance to dexmedetomidine or local anesthetics.
History of chronic pain syndromes or opioid dependence.
Pregnant or breast feeding women.
Significant co-morbidities.
Inability to communicate effectively or understand study instructions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether the addition of dexmedetomidine to the local anesthetic solution used in supra-clavicular block reduces the incidence of rebound pain in patients undergoing upper limb surgeries compared to those receiving local anesthetics alone.  first 24 hours from the time of drug injection 
 
Secondary Outcome  
Outcome  TimePoints 
Compare rebound pain in dexmedetomidine vs. control.
Analyse opioid use post-surgery with/without dexmedetomidine.
Assess block onset/duration with dexmedetomidine.
Investigate adverse effects of dexmedetomidine. 		 Every 10 mins from block given and first 24 hours from the time of drug injection 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   21/08/2025 
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="1"
Months="6"
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  

1.   Introduction :

Regional anesthesia is common for upper limb and upper thorax surgeries, but the ideal local anesthetic remains uncertain. Bupivacaine and lignocaine are standard, while dexmedetomidine, an α2-receptor agonist, is being explored as an adjuvant. Our trial evaluated dexmedetomidine’s addition to bupivacaine and lignocaine for supra-clavicular brachial plexus block, aiming to reduce local anesthetic doses and rebound pain.

2.   Research questions :

In patients undergoing upper limb surgeries receiving supra-clavicular block, does the addition of dexmedetomidine as an adjuvant affect the incidence and severity of rebound pain compared to supra-clavicular block without dexmedetomidine?

3.   Research hypothesis-

Null Hypothesis: There is no significant difference in the occurrence of rebound pain between patients receiving supraclavicular block with dexmedetomidine and those without dexmedetomidine.

Alternative Hypothesis: There is a significant difference in the occurrence of rebound pain between patients receiving supraclavicular block with dexmedetomidine and those without dexmedetomidine

Study procedure:  (briefly explained in Sequence) 

  1. After approval of Ethical committee
  2. After obtained informed written consent from the patient
  3. Patients will be divided into two groups
  4. GROUP A: Patients receiving supra-clavicular block with dexmedetomidine as an adjuvant along with the local anesthetic.
  5. GROUP B: Patients receiving supra-clavicular block without dexmedetomidine, but with 
  6. the same local anesthetic used in the dexmedetomidine group.
  7. Rescue analgesic requirement in the first 24 post-operative hours
  8. Visual Analogue Scale(VAS) scores at 0-10 and 24h until the first analgesic request
  9. Incidence of rebound pain associated with supra-clavicular nerve block with or without dexmedetomidine
  10. Correlation of data and comparison of post-operative analgesia provided by  supra-clavicular nerve block with or without dexmedetomidine

 
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