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CTRI Number  CTRI/2024/03/063894 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study comparing two different doses of Injection Buprenorphine when added to Injection Levobupivacaine (0.5% concentration) for ultrasound guided supraclavicular brachial plexus nerve block in elective upper limb surgeries. 
Scientific Title of Study   A comparative study between two different doses of buprenorphine as an adjuvant to 0.5% levobupivacaine in ultrasound guided 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  Dr Kaushalya Prakashrao Shinde 
Designation  Junior Resident 
Affiliation  Mgm Medical college 
Address  Room No 10 fifth floor MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD MAHARASHTRA Aurangabad MAHARASHTRA 431003 India

Aurangabad
MAHARASHTRA
431003
India 
Phone  9130212146  
Fax    
Email  kaushalyashinde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod bhale  
Designation  Professor 
Affiliation  Mgm medical college 
Address  Department of Anesthesia MGM Medical college and hospital N6 CIDCO Aurangabad Maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  8888819021  
Fax    
Email  pramod.bhale@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pramod bhale  
Designation  Professor 
Affiliation  Mgm medical college 
Address  Department of Anesthesia MGM Medical college and hospital N6 CIDCO Aurangabad Maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  8888819021  
Fax    
Email  pramod.bhale@gmail.com  
 
Source of Monetary or Material Support  
Mgm Medical college and hospital Aurangabad Maharashtra 
 
Primary Sponsor  
Name  MGM Medical College and Hospital Aurangabad 
Address  Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad 
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 Pramod Bhale  MGM Medical college and hospital Aurangabad  OT ROOM NO 6 OT COMPLEX MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA 		 8888819021

pramod.bhale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: S529||Unspecified fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine Plus Buprenorphine  Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 2 microgram per kilogram buprenorphine under ultrasound guidance.  
Intervention  Levobupivacaine Plus Buprenorphine  Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 3 microgram per kilogram buprenorphine under ultrasound guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patient of asa physical grade 2
18 to 65 year age
both sexes
posted for elective surgeries of upper limb 
 
ExclusionCriteria 
Details  history of infection at the site of block
coagulopathies
patient with known hypersensitivity to lacal anaesthetics
pregnant women
preexisting coagulopathies
neck deformities 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Heart rate
2)Mean arterial pressure
3)Saturation 		 1)Time at which procedure of giving block is
finished.
2)Five minute
3)Ten minute
3)Fifteen minute
4)Twenty minute
5)Fourty minute 
 
Secondary Outcome  
Outcome  TimePoints 
1.Heart rate
2.Mean arterial pressure
3.Intraoperative sedation score
 		 1)Sixty minute
2)Eighty minute
3)Hundred minute
4)One twenty minute
5)One fourty minute 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   08/04/2024 
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 Yet Recruiting 
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 - 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [kaushalyashinde@gmail.com].

  6. For how long will this data be available start date provided 15-12-2023 and end date provided 26-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary    usg guided brachial plexus block is one of the most popular peripheral nerve block techniques has become forst choice of anaesthesia for upper extremity surgery as it is minimally alert systemic physiology . ultrasound imaging allow direct visulisation of peripheral nerve s, the block needle tip and the local anaesthetic distribution.levobupivacaine ,the pure enantiomer of bupivacaine ,has less cardiac and central nervous system toxicity compared to bupivacaine .buprenorphine is u -receptor partial agonist oipiod similar in structure to morphinebut 33 time more potent than morphine .this study compare the effect of two different doses of BUPRENORPHINE as an aduvant added to 0.5% levobupivacaine . in our study we are using usg guide techniques of supraclavicula brachial plexus block 
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