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CTRI Number  CTRI/2025/03/083310 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Is Pregabalin effective is reducing pain, nausea and vomiting that happens commonly after laparoscopic cholecystectomy  
Scientific Title of Study   A comparative analysis of oral pregabalin versus placebo in managing postoperative pain, nausea and vomiting in patients undergoing laparoscopic cholecystectomy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KHUSHBOO KUMARI GUPTA 
Designation  PGT 
Affiliation  ESI PGIMSR ESIC Medical College and Hospital  
Address  Esic Medical College and hospital, Esic staff quarter A, 12th floor, 12-D, Joka, Kolkata
Puja market, sasamusa, Gopalganj, Bihar 841505
South Twentyfour Parganas
WEST BENGAL
700104
India 
Phone  9903138923  
Fax    
Email  Khushboo.gupta0304@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. MANAS RANJAN PANIGRAHI 
Designation  PROFESSOR 
Affiliation  ESI PGIMSR ESIC Medical College and Hospital  
Address  Room no. 302, Department of Anaesthesia, Esic medical college and hospital, Joka, Kolkata

South Twentyfour Parganas
WEST BENGAL
700104
India 
Phone  9836368125  
Fax    
Email  rashmimanas1976@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KHUSHBOO KUMARI GUPTA 
Designation  PGT 
Affiliation  ESIC Medical College and Hospital  
Address  Room no. 303, Department of Anaesthesia, Esic medical college and hospital, Joka, Kolkata

South Twentyfour Parganas
WEST BENGAL
700104
India 
Phone  9903138923  
Fax    
Email  Khushboo.gupta0304@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology ESI- PGIMSR, ESIC Medical College, Diamond Harbour Rd, Bratachari Gram, Joka, Kolkata, West Bengal 700104 
 
Primary Sponsor  
Name  ESI PGIMSR AND ESIC MEDICAL COLLEGE JOKA 
Address  Esic medical college and hospital, Diamond harbour, Rd, Bratachari Gram, Joka, Kolkata, West Bengal 700104 
Type of Sponsor  Government 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 Khushboo kumari gupta  Esi-pgimsr, Esic medical college and hospital  Department of Anaesthesia, Esic medical college and hospital, Diamond Harbour Rd, Bratachari Gram, Joka, Kolkata, West Bengal, 700104
South Twentyfour Parganas
WEST BENGAL 
9903138923

khushboo.gupta0304@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: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sugar pill   Sugar pill similar in taste and appearance to pregabalin  
Intervention  Tablet Pregabalin 75 mg  Pregabalin tablet will be given in dose of 75 mg, once in the morning one hour before surgery, given by oral route, single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2
Patient posted for elective laparoscopic cholecystectomy  
 
ExclusionCriteria 
Details  1.Patient refusal to participate
2.Patient with ASA physical status 3 or more
3. History of drug or alcohol abuse
4.History of chronic pain
5.Patients with impaired kidney or liver function
6. History of allergy or contraindication to pregabalin or Gabapentin.
7. History of post operative nausea and vomiting in patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
analyse the effect of oral pregabalin in managing postoperative pain using VAS(Visual Analog Scale). • To assess the incidence of post operative nausea, vomiting using four point ordinal score.  I will assess the patient till 24 hour after giving Pregabalin tablet 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time of first rescue analgesic drug.
To assess the incidence of post operative nausea using four point ordinal score.
To assess the incidence of post operative vomiting using four point ordinal score.
To assess incidence of complications e.g. sedation, respiratory depression arising from using oral pregabalin.  
I will assess the patient till 24 hour after giving pregabalin tablet 
 
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 2/ Phase 3 
Date of First Enrollment (India)   04/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - NO
Brief Summary  

Laparoscopic cholecystectomy is one of the most common surgical procedures, however pain , nausea vomiting after this surgery is very frequent. Pain results to physiological and psychological response in patients which is detrimental to the postoperative outcomePathophysiology of pain have suggested that the central neural hyperexcitability that contributes to enhanced postoperative pain is preventable.  Different agents have been employed for preemptive analgesia such as nonsteroidal anti inflammatory drugs, NMDA antagonist and gamma amino butryic acid(GABA) analogues. Opioids are first alternative to treat moderate to severe pain but have adverse effects such as nausea , vomiting, respiratory depression and urinary retention. PONV is common in laparoscopic cholecystectomy. Nausea is a conscious recognition of subconscious excitation in an area of the medulla closely associated with or a part of vomiting centre, or it’s a sensation of discomfort in the upper abdomen and a sensation of unease with voluntary urge to vomit. Gabapentin has been used in managing postoperative pain and PONV. Compared to gabapentin, pregabalin pharmacokinetic is seen more favourable with better, faster, and more predictable absorption.


 
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