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CTRI Number  CTRI/2025/06/089520 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
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   A Comparison Between 0.5 Percentage Bupivacaine and 0.5 Percentage Ropivacaine with Dexamethasone as an Adjuvant in Supraclavicular Brachial Plexus Block. 
Scientific Title of Study   A Comparative Study Between 0.5 Percentage Bupivacaine and 0.5 Percentage Ropivacaine with Dexamethasone as an Adjuvant in Supraclavicular Brachial Plexus Block. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Balaji Wadikar 
Designation  JUNIOR RESIDENT 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre 
Address  Department of Anaesthesia, 5th Floor, Hi-tec building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9404265478  
Fax    
Email  priyankabw0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shahbaz Hasnain 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre 
Address  Department of Anaesthesia, 5th Floor, Hi-tec building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764621253  
Fax    
Email  shahbazhsnn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shahbaz Hasnain 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Dr. D.Y. Patil Medical College, Hospital and Research Centre 
Address  Department of Anaesthesia, 5th Floor, Hi-tec building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764621253  
Fax    
Email  shahbazhsnn@gmail.com  
 
Source of Monetary or Material Support  
Central Pharmacy ,5th floor ,Hi-tech building, Dr. D. Y. Patil Medical college ,Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India - 411018 
 
Primary Sponsor  
Name  Priyanka Balaji Wadikar 
Address  Department of Anaesthesia, 5th Floor, Hi-tec building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune  
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 Priyanka Balaji Wadikar  Dr. D.Y. Patil Medical College, Hospital and Research Centre  Department of Anaesthesia, 5th Floor, Hi-tec building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 9404265478

priyankabw0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Recognition 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  BUPIVACAINE WITH DEXAMETHASONE   28ml of 0.5% Bupivacaine along with 2ml of Dexamethasone was administered in Supraclavicular Brachial Plexus Block.  
Comparator Agent  ROPIVACAINE WITH DEXAMETHASONE   28ml of 0.5% Ropivacaine along with 2ml of Dexamethasone was administered in Supraclavicular Brachial Plexus Block.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA grade 1 or 2 fit patients
2.Patients aged between 18-60 years of age
3.Both Male and Female gender
4.Patients posted for upper limb surgeries below shoulder
5.Hemodynamically stable patients with all routine investigations within normal limits.
6.Written informed consent from the concerned patients. 
 
ExclusionCriteria 
Details  1.Patients with ASA grade3 and above physical status.
2.Known allergy or contraindication to either bupivacaine or ropivacaine.
3.Patients with bleeding disorders and those on anticoagulant therapy
4.pre-existing sensory or motor deficits in the upper extremity.
5.History of neurological or psychiatric disorders affecting perception or cooperation
6.Pregnant women
7.Patients with significant comorbidities that could affect the safety of the procedure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate Onset of Sensory and Motor Blockade And to Assess Duration of Sensory and Motor blockade And to compare Postoperative Pain control   Baseline, 5min, 10min, 15min, 30min, End of Surgery, 2 Hours after Surgery, 4 Hours after Surgery, 6 Hours after Surgery, 8 Hours after Surgery, 10 Hours after Surgery, 12 Hours after Surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess of Hemodynamic response And to examine the Incidence of Adverse Events  To monitor HR,BP,SPO2 At 0 min ,5min,10 min,15 min,30min,2hrs after surgery 4 hrs after surgery,6hrs after surgery,8hrs after surgery,10hrs after surgery,12hrs after surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   24/07/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 15-10-2024 and end date provided 23-10-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It is a prospective, randomized, double blinded comparative study to assess and compare the efficacy, onset, duration and safety profiles between 0.5% Bupivacaine and 0.5% Ropivacaine with Dexamethasone as an adjuvant in Supraclavicular plexus block in patients undergoing forearm surgeries .

Parameters that will be compared between the two groups will be the onset and duration of action of sensory and motor blockade, duration of analgesia and time  to rescue analgesia.  
 
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