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CTRI Number  CTRI/2025/09/094268 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare Bupivacaine vs Bupivacaine and Dexmedetomidine given in joint for Postoperative pain in Arthroscopic Knee surgery patients 
Scientific Title of Study   Comparison of intra-articular Bupivacaine vs Bupivacaine and Dexmedetomidine for Postoperative Analgesia in Arthroscopic Knee surgery patients 
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 Inderjeet Singh 
Designation  PG Resident 
Affiliation  Adesh Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research,Bathinda,151001, India

Bathinda
PUNJAB
151001
India 
Phone  8284882936  
Fax    
Email  ind2936@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Usha Devi 
Designation  Associate professor 
Affiliation  Adesh Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research,Bathinda,151001, India

Bathinda
PUNJAB
151001
India 
Phone  9915461044  
Fax    
Email  sonaattri45@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Inderjeet Singh 
Designation  PG Resident 
Affiliation  Adesh Institute of Medical Sciences and Research 
Address  Department of Anesthesiology and Intensive Care, Adesh Institute of Medical Sciences and Research,Bathinda,151001, India

Bathinda
PUNJAB
151001
India 
Phone  8284882936  
Fax    
Email  ind2936@gmail.com  
 
Source of Monetary or Material Support  
Adesh University, Bathinda, 151001,Punjab,India 
 
Primary Sponsor  
Name  Adesh University 
Address  Adesh Institute of Medical Sciences and Research Bathinda,Punjab,151001 
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 Inderjeet Singh  Adesh hospital  OT Complex of Anesthesiology and Intensive care department
Bathinda
PUNJAB 		 8284882936

ind2936@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE ADESH UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BUPIVACAINE (0.5%) 1ML AND DEXMEDETOMIDINE (50MCG) 14ML intraoperative at end of surgery   GIVEN INTRA ARTICULAR IN KNEE JOINTS 
Intervention  BUPIVACAINE(O.5%) 14 ml + 1ml NS intraoperative at end of surgery  GIVEN INTRA ARTICULAR IN KNEE JOINTS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA (American Society of Anaesthesiologists) physical status I and II
Age:18-60 years
Patients scheduled for elective arthroscopic knee surgeries under spinal anesthesia
Duration of surgery between 90-150 minutes
 
 
ExclusionCriteria 
Details  patients allergic to this drug, coagulation disorders , pregnant females , sepsis present , obesity
 
 
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 
compare post op pain   compare post op pain FOR 24 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
haemodynamics changess  post op FOR 24 HOURS 
 
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 2 
Date of First Enrollment (India)   17/09/2025 
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="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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [ind2936@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   we are comparing effect on post op pain by bupivacaine vs bupivacaine and dexmedetomidine given intra articular in arthroscopic knee surgery patients in next 24 hours. 
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