| 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
|
|
|
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
|
|
|
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 outcome. Pathophysiology 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.
|