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CTRI Number  CTRI/2026/04/109487 [Registered on: 27/04/2026] Trial Registered Prospectively
Last Modified On: 19/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the effectiveness of dexamethasone and fentanyl in improving pain relief during and after upper limb surgery using nerve block. 
Scientific Title of Study   A Randomized Comparative Study Of Dexamethasone and Fentanyl as an Adjuvant to 0.5 percentge Ropivacaine in Usg Guided Supraclavivular Brachial Plexus Block In Upper Limb Surgeries 
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 Jayesh Choudhary 
Designation  Resident Anaesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anaesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9664075494  
Fax    
Email  The.drjayesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Chandra Audichya 
Designation  Proffesor and Head of the Department of Anesthesiology 
Affiliation  Pacific Medical College and Hospital Udaipur 
Address  Department of Anesthesiology and Critical care , 3rd floor, Pacific Medical College and Hospital, Bhilon ka Bedla,Udaipur, Rajasthan , 313001, india Udaipur RAJASTHAN 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone  9929721889  
Fax    
Email  prakash.audichya10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Chandra Audichya 
Designation  Proffesor and Head of the Department of Anesthesiology 
Affiliation  Pacific Medical College and Hospital Udaipur 
Address  Department of Anesthesiology and Critical care , 3rd floor, Pacific Medical College and Hospital, Bhilon ka Bedla,Udaipur, Rajasthan , 313001, india Udaipur RAJASTHAN 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone  9929721889  
Fax    
Email  prakash.audichya10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, Third Floor Main Camus , Pacific Medical College and Hospital Udaipur Rajasthan Pin Code 313001 
 
Primary Sponsor  
Name  PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  Department of Anaesthesiology and Critical care, Pacific Medical College and Hopsital,Third Floor, Bilo Ka bedla ,Udaipur, Rajasthan Pin Code 313001 
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 Jayesh Choudhary  Pacific Medical college and Hospital  Department of Anesthesiology and Critical care, Third Floor, Pacific Medical college and Hospital ,Bilo ka bedla Udaipur,Rajasthan
Udaipur
RAJASTHAN 		 9664075494

the.drjayesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee Pacific Medical College And Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S423||Fracture of shaft of humerus, (2) ICD-10 Condition: S498||Other specified injuries of shoulder and upper arm, (3) ICD-10 Condition: S422||Fracture of upper end of humerus, (4) ICD-10 Condition: S424||Fracture of lower end of humerus, (5) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Use of dexamethasone as a adjuvant to ropivacaine in ultrasound-guided supraclavicular brachial plexus block.   Ropivacaine 0.5% (24 ml) with dexamethasone 4 mg administered perineurally in ultrasound-guided supraclavicular brachial plexus block. 
Comparator Agent  Use of fentanyl as a adjuvant to ropivacaine in ultrasound-guided supraclavicular brachial plexus block.  Ropivacaine 0.5% (24 ml) with fentanyl 50 mcg administered perineurally in ultrasound-guided supraclavicular brachial plexus block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients giving consent
ASA Grade-I and II
 
 
ExclusionCriteria 
Details  Lack of patient consent
Patient refusal
ASA Grade-IV and V
Patients with anticipated difficult intubation
Mallampati Grade-III and IV
Allergic to local anaesthetics
Coagulation disorder
6. Uncontrolled HTN and DM
 
 
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 efficacy onset of sensory and motor block , duration of sensory and motor block following administration of study drug in ultrasound-guided supraclavicular brachial plexus block.   to document sensory and motor block at Baseline, every 5 minutes until onset of blockade, intraoperatively, then hourly until complete recovery from blockade. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Duration of analgesia, time to first rescue analgesic, total rescue analgesic consumption in 24 hours, hemodynamic parameters (heart rate & mean arterial pressure measured at baseline, 1, 3, 5, 10, 15, 20, 30 minutes & intraoperatively), block quality assessment using sensory (pinprick method) & motor block grading, & incidence of adverse effects such as nausea, vomiting, bradycardia, hypotension, & local anesthetic toxicity.   Baseline, 05,10,15,20,30,60,90,120 min intraoperatively. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   N/A 
Date of First Enrollment (India)   10/05/2026 
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="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   The randomized double - blind comparative study that aims to evaluate the effect of dexamethasone and fentanyl  as adjuvants to 0.5% ropivacaine in ultrasound-guided supraclavicular brachial plexus block in patients undergoing elective upper limb surgeries. The study will assess onset and duration of sensory and motor block, duration of analgesia, time to first rescue analgesic, and hemodynamic parameters. 
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