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IRCT20260701070034N1 IRCT 2026-07-08 National Hospital and Medical Center Lahore Does Intravenous Ibuprofen Reduce the Need for Opioid Pain Medicines After Laparoscopic Cholecystectomy? IVI-LOC Trial OPIOID SPARING EFFECT OF INTRAVENOUS IBUPROFEN IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY 2026-07-10 anticipated 60 Recruiting https://irct.ir/trial/91386 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: The randomization will be blinded to all assessors. N/A Gallstone disease undergoing Laparoscopic cholecystectomy. Intervention 1: Intervention group (ibuprofen group): patients will receive 400mg (100ml) of intravenous ibuprofen over 20 minutes, 20 minutes before extubation. Intervention 2: Control group: patients will receive 100 ml of intravenous normal saline over 20 minutes, 20 minutes before extubation. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be shared due to confidentiality and institutional policy.
public Muhammad Majid Khan
132/3, L-Block, near sports stadium D.H.A Lahore Cantt
Lahore Pakistan 54810 +92 305 5969114 drmajid505@gmail.com National Hospital And Medical center Lahore scientific Ethics committee of National Hospital And Medical Center
132/3, L-Block, near sports stadium D.H.A Lahore Cantt
Lahore Pakistan 54810 +92 305 5969114 drmajid505@gmail.com National Hospital And Medical center Lahore Pakistan 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. 18 years 65 years Both 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). K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Drugs Placebo Intervention group (ibuprofen group): patients will receive 400mg (100ml) of intravenous ibuprofen over 20 minutes, 20 minutes before extubation. Control group: patients will receive 100 ml of intravenous normal saline over 20 minutes, 20 minutes before extubation. Postoperative opioid consumption. Timepoint: 24 hours post-operatively. Method of measurement: total dose of rescue analgesia administered based on VAS score. National Hospital and Medical Center Lahore Approved 2024-07-26 Ethics committee of National Hospital And Medical Center 132/3, L-Block, near sports stadium D.H.A Lahore Cantt Lahore Punjab Pakistan