Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

Completed 154 enrolled Seoul National University Hospital Kyongbo Pharmaceutical · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (RARP). We hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing RARP.

Timeline

Start: 2023-02-10
Primary completion: 2025-02-28
Completion: 2025-07-30

Outcome

Missed primary endpoint

paper rest pain burden showed no statistically significant between-group difference (mean difference − 6.7, 95% CI − 21.7 to 7.3; Cohen’s d = − 0.14; P = 0.378). PMID 41790365 ↗

Publications

Youssof HA, Hassan AA, Saleh AA, Shafiea A, Mohammed AM, Elsayed AS, Metwally ME, Abdelkhalek NA, Hassan GM, Elebiary MF, Lotfy AA, Sharawy A. Preemptive versus preventive intravenous acetaminophen/ibuprofen fixed-dose combination after robot-assisted radical prostatectomy: a comprehensive secondary analysis of a public double-blind randomized dataset. J Robot Surg. 2026 Mar 6;20(1):320. doi: 10.1007/s11701-026-03239-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	1000 mg	Intravenous
Subject	Ibuprofen	Small molecule	300 mg	Intravenous

Indications

No indication recorded.