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CTRI Number  CTRI/2024/10/074759 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of oral dexamethasone versus intravenous dexamethasone on pain relief duration in patients having orthopaedic upper limb surgery under supraclavicular brachial plexus block 
Scientific Title of Study   Effect of oral versus intravenous dexamethasone on duration of analgesia after osseous upper limb surgery under 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  Akshay Sharma 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room no. 303, BL Taneja Block, Department of Anaesthesia, Maulana azad medical college

Central
DELHI
110002
India 
Phone  7009130873  
Fax    
Email  sharmaakshay6048@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anju Romina Bhalotra 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room no. 303, BL Taneja Block, Department of Anaesthesia, Maulana azad medical college

Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Akshay Sharma 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room no. 303, BL Taneja Block, Department of Anaesthesia, Maulana azad medical college

Central
DELHI
110002
India 
Phone  7009130873  
Fax    
Email  sharmaakshay6048@gmail.com  
 
Source of Monetary or Material Support  
Lok Nayak Hospital, Jawahar Lal Nehru Marg, New Delhi, 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, New Delhi, 110002 
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 
Akshay Sharma  Lok Nayak Hospital  Operation theatre Block, Lok Nayak Hospital, JLN Marg, New Delhi 110002
Central
DELHI 		 7009130873

sharmaakshay6048@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Maulana Azad Medical College  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 
Comparator Agent  intravenous dexamethasone  intravenous dexamethasone given simultaneously at the time of administration of supraclavicular brachial plexus block 
Intervention  oral dexamethasone  oral dexamethasone 12 mg given as tablet 2 hours before giving supraclavcular brachial plexus block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  adult patients between the age of 18-60 years scheduled to undergo elective upper limb orthopaedic surgery under supraclavicular brachial plexus block
patients belonging to Amercian Society of Anaesthesiologists(ASA) PHYSICAL STATUS I - III  
 
ExclusionCriteria 
Details  1. Any contraindications to supraclavicular brachial plexus block (deformity of shoulder, coagulopathy, local skin infection, bleeding diathesis).
2. History of hypersensitivity to study drug.
3. History of alcohol abuse, chronic analgesic drug therapy, psychoactive drug use
4. Significant cognitive or psychiatric illness.
5. Known case of diabetes mellitus.
6. Pre-existing nerve disease or neuropathy in upper limb.
7. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia  Pain score in the patient will be assessed in the post operative room immediately after the surgery and at 2,6,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of motor blockade  Time from completing administration of supraclavicular brachial plexus block to first report of restoration of finger movement in the individual 
Post op pain scores  Pain scores at 0, 6, 12 and 24 hours after surgery according to NRS method 
Average post op pain score  Taking the mean of NRS score at 0, 6,12 and 24 hours 
Recovery quality after the 24 hours  QOR-15 quality of recovery score to be done at 24 hours 
Analgesic consumption over first 24 hours  Total consumption of the patient in the first 24 hours post operatively will be noted 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 18/10/2024 
Date of Study Completion (India) 21/08/2025 
Date of First Enrollment (Global)  18/10/2024 
Date of Study Completion (Global) 21/08/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  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) -  Proposals should be directed to sharmaakshay6048@gmail.com

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This prospective, randomized, double-blind controlled trial evaluates methods to prolong postoperative analgesia following ultrasound-guided supraclavicular brachial plexus block (SBPB) for upper limb orthopedic surgery. Adult ASA I–III patients undergoing unilateral forearm or hand osseous surgery will be randomized to receive either oral dexamethasone 12 mg two hours before surgery with intravenous placebo, or intravenous dexamethasone 8 mg at the time of block with oral placebo. All patients will receive oral etoricoxib 90 mg preoperatively as part of a standardized multimodal analgesic regimen.

SBPB will be performed using ropivacaine in all patients. The primary outcome is the duration of analgesia, defined as time to first postoperative pain requiring rescue analgesia. Secondary outcomes include postoperative pain scores, quality of recovery, and adverse effects. The study aims to determine whether oral dexamethasone provides analgesia comparable to intravenous dexamethasone.

 
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