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CTRI Number  CTRI/2024/05/067288 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare dexamethasone and dexmeditomidine as additive with local anaesthetic in shoulder surgeries. 
Scientific Title of Study   A comparative study to know the analgesic efficacy of dexamethasone and dexmedetomidine as adjuvant to levobupivacaine for interscalene brachial plexus block in patients undergoing orthopaedic shoulder surgeries - A randomised clinical 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 Prabhu S Angadi 
Designation  Post Graduate/ Junior Resident 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre Vijayapur. 
Address  Department of Anaesthesia B.L.D.E (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre Vijayapur.

Bijapur
KARNATAKA
586103
India 
Phone  8832138600  
Fax    
Email  drprabhu.angadi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay V Katti 
Designation  Associate Professor 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre Vijayapur. 
Address  Department of Anaesthesia B.L.D.E (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre Vijayapur.

Bijapur
KARNATAKA
586103
India 
Phone  9844585900  
Fax    
Email  drvijaykatti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prabhu S Angadi 
Designation  Post Graduate/ Junior Resident 
Affiliation  Shri B M Patil Medical College Hospital and Research Centre Vijayapur. 
Address  Department of Anaesthesia B.L.D.E (Deemed to be University) Shri B M Patil Medical College Hospital and Research Centre Vijayapur.

Bijapur
KARNATAKA
586103
India 
Phone  8832138600  
Fax    
Email  drprabhu.angadi@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Shri B M Patil Medical College Hospital and Research Centre B.L.D.E (Deemed to be University) Vijayapur 586103 Karnataka state India. 
 
Primary Sponsor  
Name  Shri B M Patil Medical College Hospital and Research Centre Vijayapur 
Address  Department of Anaesthesia Shri B M Patil Medical College Hospital and Research Centre. B.L.D.E (Deemed to be University) Vijayapur 586103 Karnataka state India. 
Type of Sponsor  Research institution and hospital 
 
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 Prabhu Angadi  Shri B M Patil Medical College Hospital and Research Centre Vijayapur.  Department of Anaesthesia B.L.D.E (Deemed to be University) Vijayapur 586103.
Bijapur
KARNATAKA 		 8892138600

drprabhu.angadi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri B M Patil Medical College Hospital and Research Centre. B.L.D.E (Deemed to be University) Vijayapura  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  Dexamethasone  Dexamethasone 8 mg is used as additive to 25ml 0.5% levobupivacaine in interscalene brachial plexus block 
Comparator Agent  Dexmeditomidine  Dexmeditomidine 50 mcg is used as additive to 25ml 0.5% levobupivacaine in interscalene brachial plexus block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients admitted for shoulder surgeries under interscalene brachial plexus block with ASA grade I and II 
 
ExclusionCriteria 
Details  1. Infection at the site of injection.
2. Known allergy/hypersensitivity to local anaesthetic drug.
3. presence of coagulopathies.
4. A history of cardiac, respiratory, hepatic and renal failure and those who refused local amaesthesia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Assess onset and duration of sensory block.
2. Assess onset and duration of motor block.
3. To evaluate additive effects of dexamethasone and dexmeditomidine to levobupivacaine 		 baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor intraoperative hemodynamic stability.  baseline 
To study the time taken for first rescue analgesia & requirement of total dose of rescue analgesia.  24 hours 
To study ISBPB related post operative complications.  24 hours 
Assessment of post operative visual analogue scores for both groups at 2, 6, 8, 10, & 12 hours after surgery, patient satisfaction score at 24h  24 hours 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drprabhu.angadi@gmail.com].

  6. For how long will this data be available start date provided 30-04-2024 and end date provided 29-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is aimed at evaluating the analgesic effect, onset of sensory and motor block, duration of action, postoperative visual analogue score and additive effects of dexamethasone and dexmeditomidine to levobupivacaine for  interscalene block in shoulder surgeries. 
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