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CTRI Number  CTRI/2024/12/077716 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing effects of various adjuvants added to anaesthetic agent in patients undergoing lower limb surgery under a combination of Spinal Anaesthesia and lumbar and sacral plexus blocks 
Scientific Title of Study   A Prospective Randomised Control trial to compare the Haemodynamic effects and duration of Anaesthesia of Adrenaline, Buprenorphine, and Dexmedetomidine, when used as adjuvants in in Low Dose Spinal Anaesthesia in combination with Lumbar and Sacral Plexus Blocks, for lower limb surgery 
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 Nikhil Karkhanis 
Designation  Associate Professor  
Affiliation  Vikhe Patil Institute of Medical Sciences 
Address  Dept of Anaesthesiology Vikhe Patil Institute of Medical Sciences Vilad Ghat Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  09977000738  
Fax    
Email  nikhilkarkhanis@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhil Karkhanis 
Designation  Associate Professor 
Affiliation  Vikhe Patil Institute of Medical Sciences 
Address  Dept of Anaesthesiology Vikhe Patil Institute of Medical Sciences Vilad Ghat Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  09977000738  
Fax    
Email  nikhilkarkhanis@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Karkhanis 
Designation  Associate Professor 
Affiliation  Vikhe Patil Institute of Medical Sciences 
Address  Dept of Anaesthesiology Vikhe Patil Institute of Medical Sciences Vilad Ghat Ahmednagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  09977000738  
Fax    
Email  nikhilkarkhanis@rediffmail.com  
 
Source of Monetary or Material Support  
Vikhe Patil Institute of Medical Sciences Vilad Ghat Ahmednagar Maharashtra India 414111 
 
Primary Sponsor  
Name  Vikhe Patil Institute of Medical Sciences 
Address  Vilad Ghat Ahmednagar Maharashtra India 414111 
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 Nikhil Karkhanis  Vikhe patil Institute of Medical Sciences  Dept of Anaesthesiology Vikhe Patil Institute of Medical Sciences Vilad Ghat Ahmednagar 414111
Ahmadnagar
MAHARASHTRA 		 9977000738

nikhilkarkhanis@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vikhe Patil Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S72||Fracture of femur, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: S729||Unspecified fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adrenaline as adjuvant in Low dose spinal with lumbar and sacral plexus blocks  Safety, efficacy, haemodynamic effects and duration of effect 
Comparator Agent  Buprenorphine as adjuvant in low dose spinal with lumbar and sacral plexus blocks  Safety, efficacy, haemodynamic effects and duration of effect 
Comparator Agent  Dexmedetomidine as adjuvant in Low dose spinal with lumbar and sacral plexus blocks  Safety, efficacy, haemodynamic effects and duration of effect 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients undergoing lower limb surgeries including trauma surgery
2. Age above 18
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
A Prospective Randomised Control trial to compare the Haemodynamic effects and duration of Anaesthesia of Adrenaline, Buprenorphine, and Dexmedetomidine, when used as adjuvants in in Low Dose Spinal Anaesthesia in combination with Lumbar and Sacral Plexus Blocks, for lower limb surgery.  15 minute interval during surgery and at 2 hourly intervals post operative, until analgesic is required, at which point the study is terminated 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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 3/ Phase 4 
Date of First Enrollment (India)   23/12/2024 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Clinical Study Report

  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 - Proposals should be directed to [nikhilkarkhanis@rediffmail.com].

  6. For how long will this data be available start date provided 27-01-2025 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
  1. A Prospective Randomised Control trial to compare the Haemodynamic effects and duration of Anaesthesia of Adrenaline, Buprenorphine, and Dexmedetomidine, when used as adjuvants in in Low Dose Spinal Anaesthesia in combination with Lumbar and Sacral Plexus Blocks, for lower limb surgery.
 
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