| CTRI Number |
CTRI/2025/06/088605 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effects of two drugs,ibuprofen and paracetamol in patients undergoing laparoscopic cholecystectomy surgery |
|
Scientific Title of Study
|
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative
Pain and Tramadol Consumption After Laparoscopic Cholecystectomy
Surgery: A Prospective, Randomized, Clinical Trial |
| 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 Lakshman P |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9740165283 |
| Fax |
|
| Email |
lakshmanpadiyappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839927283 |
| Fax |
|
| Email |
rajeevdubeyrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences BHU Varanasi Uttar Pradesh India Pincode 221005 |
|
|
Primary Sponsor
|
| Name |
Lakshman P |
| Address |
Junior Resident Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India Pincode - 221005 |
| Type of Sponsor |
Other [] |
|
|
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 Rajeev Kumar Dubey |
Institute of medical sciences BHU |
Department of Anaesthesiology Sir Sunderlal hospital BHU
Varanasi
UTTAR PRADESH |
9839927283
rajeevdubeyrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K811||Chronic cholecystitis, (2) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (3) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Ibuprofen |
Intravenous Ibuprofen
Dosage: 800 mg
Route: Intravenous infusion
Timing: Administered 30 minutes before the end of laparoscopic cholecystectomy
Frequency: Single dose
Purpose: To evaluate its efficacy in reducing postoperative pain intensity |
| Comparator Agent |
Intravenous Paracetamol |
Intravenous Paracetamol
Dosage: 1 gram
Route: Intravenous infusion
Timing: Administered 30 minutes before the end of laparoscopic cholecystectomy
Frequency: Single dose
Purpose: To compare analgesic efficacy with intravenous ibuprofen for postoperative pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients Aged 18 To 85 Years.
Patients With American Society of Anesthesiologists (ASA) Physical Status Scores
Ranging From 1 To 3.
Patients Who Are Given Consent and Willing to Participate in This Study.
|
|
| ExclusionCriteria |
| Details |
Patients Classified as Having an ASA Score of IV
Those Falling Outside the Specified Age Range.
Individuals With Peptic Ulcers, Severe Hepatic or Renal Failure, Significant
Cardiovascular or Pulmonary Conditions.
A History of Drug Allergies (Specifically, Propofol, Fentanyl, Rocuronium, Paracetamol,
Ibuprofen, And Tramadol).
As Well As Cases of Emergency Surgery.
Individuals Who Did Not Provide Informed Consent. |
|
|
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 |
| •The primary objective of this study was to assess and compare the impact of iv ibuprofen and paracetamol on postoperative pain intensity through numeric rating scale . |
Post operative 1st, 6th, 12th, and 24th hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As secondary objectives, this study assesses tramadol consumption as rescue analgesic, analyzes intraoperative hemodynamic parameters, and the investigates any adverse effects related to study drugs in patients who underwent laparoscopic cholecystectomy surgery. |
intraoperatively baseline , 5minutes ,10minutes ,30minutes ,60minutes ,90minutes ,120minutes
postoperatively 1st hour ,6th hour ,12th hour ,24th hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
18/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Title Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain After Laparoscopic Cholecystectomy Surgery A Prospective Randomized Clinical Trial
Brief Summary This prospective randomized clinical trial aims to compare the analgesic efficacy of intravenous IV ibuprofen and IV paracetamol in managing postoperative pain in patients undergoing laparoscopic cholecystectomy. A total of 80 adult patients aged 18 to 65 years with ASA physical status I to III will be randomly assigned to receive either IV ibuprofen 800 mg [10mg/kg body weight] or IV paracetamol 1 g [15mg/kg body weight] administered 30 minutes before the end of surgery. Pain intensity will be assessed using the Numeric Rating Scale NRS at 1st 6th 12th and 24 hours postoperatively. The primary objective is to compare postoperative pain scores between the two groups. Secondary outcomes include rescue tramadol requirements hemodynamic parameters and adverse drug effects. The study is being conducted at the Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi. |