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CTRI Number  CTRI/2022/07/044462 [Registered on: 29/07/2022] Trial Registered Prospectively
Last Modified On: 17/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   study to compare the effect of oral pregabalin(pain killer) and oral paracetamol(pain killer) as pain relief after operation in patients undergoing leg surgeries under spinal anaesthesia 
Scientific Title of Study   Prospective randomized control study of comparison of efficacy of oral pregabalin and oral paracetamol as pre-emptive analgesics in patients receiving spinal anaesthesia for lower limb surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha Saxena  
Designation  PG Scholar  
Affiliation  Dr D Y Patil school of medicine  
Address  Depaertment of anaesthesia, school of medicine Dr D Y Patil hospital and Deemed to be University, sector 5, nerul, navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8698562596  
Fax    
Email  disha.saxenaaa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Disha Saxena  
Designation  PG Scholar  
Affiliation  Dr D Y Patil school of medicine  
Address  Depaertment of anaesthesia, school of medicine Dr D Y Patil hospital and Deemed to be University, sector 5, nerul, navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8698562596  
Fax    
Email  disha.saxenaaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raghbir Singh Gehdoo 
Designation  Professor  
Affiliation  Dr D Y Patil school of medicine 
Address  Depaertment of anaesthesia, school of medicine Dr D Y Patil hospital and Deemed to be University, sector 5, nerul, navi mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9820517674  
Fax    
Email  rpgk123@gmail.com  
 
Source of Monetary or Material Support  
School of medicine Dr D Y Patil Deemed to be University  
 
Primary Sponsor  
Name  Dr Disha Saxena 
Address  Depaertment of anaesthesia, school of medicine Dr D Y Patil hospital and Deemed to be University, sector 5, nerul, navi mumbai 
Type of Sponsor  Other [self] 
 
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 Disha Saxena  D Y Patil hospital Nerul  Department of Anaesthesia, 2nd floor,school of medicine Dr D Y Patil hospital and Deemed to be University, sector 5, nerul, navi mumbai
Thane
MAHARASHTRA 		 8698562596

disha.saxenaaa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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 
Intervention  pregabalin   patients will be given Tablet Pregabalin 140mg orally 1 hour before the surgery  
Comparator Agent  Tablet Paracetamol  patients will be given Tablet Paracetamol 1 gm orally 1 hour before the surgery 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)all patients giving consent
2)patients undergoing lower limb surgeries
3)ASA grade I and II 
 
ExclusionCriteria 
Details  Uncooperative and unwilling patients
hypersensitivity to drug
history of neurological and seizure disorder
surgeries lasting for more than 3 hours 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to find out which analgesic is better in postoperative patients undergoing lower limb surgeries under spinal anaesthesia   post operative 0 hours to 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
to find out when the first rescue analgesic was given in patients post operatively and at what time period post operative  post operative 0 hours to 12 hours  
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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/ Phase 3 
Date of First Enrollment (India)   01/08/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
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 - 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 - Any purpose.

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

  6. For how long will this data be available start date provided 20-06-2022 and end date provided 20-06-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients will be allocated into two groups containing 23 patients each. 
Group A will recieve 150 mg Pregabalin orally 1 hour before the syrgery and Group B will recieve Paracetamol 1 gm 1 hour prior to surgery 
Patient’s pain will be monitored postoperatively by using VAS scale at 1/2 , 1 1/2, 2,4,6,12 hours after the surgery  
Time of first analgesic given postoperatively will be noted.
 
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