To compare the opioid-sparing effect of intraoperative intravenous ibuprofen versus placebo in patients undergoing laparoscopic cholecystectomy, in terms of postoperative opioid consumption, pain scores, and requirement for rescue analgesia.
Design
A single-center, randomized, placebo-controlled, parallel-group trial with blinded outcome assessment involving 60 patients (30 in each group).
Settings and conduct
The study will be conducted in the Department of Anesthesia, National Hospital & Medical Center Lahore. Patients will be randomized into two groups by using the closed envelope method: the ibuprofen group (n = 30) and the control group (n = 30). The randomization will be blinded to all assessors
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age 18–65 years
ASA physical status I–II
Patients scheduled for laparoscopic cholecystectomy
Exclusion Criteria
Chronic use of NSAIDs or opioids
Intraoperative discontinuation of study protocol for any reason
Known contraindication or hypersensitivity to study drugs (ibuprofen/tramadol)
Intervention groups
Intervention Group 1:
The ibuprofen group (n = 30) will receive 400 mg (100 ml) of intravenous ibuprofen over 20 minutes, 20 minutes before extubation.
Control Group:
The control group (n = 30) will receive 100 ml of normal saline intravenously over 20 minutes, 20 minutes before extubation.
Main outcome variables
Total postoperative opioid consumption (tramadol dose in mg) within 24 hours after laparoscopic cholecystectomy. Postoperative pain scores using Visual Analogue Scale (VAS) at 2-hour intervals for up to 12 hours. Time to first rescue analgesia. Requirement for rescue analgesia (yes/no). Total dose of rescue analgesia administered.
General information
Reason for update
Acronym
IVI-LOC Trial
IRCT registration information
IRCT registration number:IRCT20260701070034N1
Registration date:2026-07-08, 1405/04/17
Registration timing:prospective
Last update:2026-07-08, 1405/04/17
Update count:0
Registration date
2026-07-08, 1405/04/17
Registrant information
Name
Muhammad Majid Khan
Name of organization / entity
National Hospital And Medical center Lahore
Country
Pakistan
Phone
+92 342 0508505
Email address
drmajid505@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-10, 1405/04/19
Expected recruitment end date
2026-09-01, 1405/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
OPIOID SPARING EFFECT OF INTRAVENOUS IBUPROFEN IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY
Public title
Does Intravenous Ibuprofen Reduce the Need for Opioid Pain Medicines After Laparoscopic Cholecystectomy?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients aged between 18 to 65 years.
2. Both Gender.
3. American Society of Anesthesiology (ASA) stage l-ll.
4. Scheduled for laparoscopic cholecystectomy.
Exclusion criteria:
l. History of long-term non-steroidal anti-inflammatory and opioid analgesic use (to eliminate potential confounding factors related to previous medication history).
2. Needing to discontinue the medication required in the study during surgery for any reason (to maintain consistency in the study protocol and avoid potential interference with the intervention).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups by using the closed envelope method: the ibuprofen group (n = 30) and the control group (n = 30). The randomization will be blinded to all assessors.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomization will be blinded to all assessors.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Hospital And Medical Center
Street address
132/3, L-Block, near sports stadium D.H.A Lahore Cantt