Efficacy of an intravenous acetaminophen/ibuprofen fixed-dose combination for postoperative catheter-related bladder discomfort in patients undergoing robot-assisted laparoscopic prostatectomy: a double-blinded, randomized, placebo-controlled study

Background: Placement of an intraoperative urinary catheter frequently leads to catheter-related bladder discomfort (CRBD) in the immediate postoperative period. We assessed the efficacy of a fixed-dose combination (FDC) of acetaminophen/ibuprofen in alleviating CRBD. Methods: In this double-blinded, active-controlled, randomized trial, adults aged 20-79 years undergoing elective robot-assisted laparoscopic radical prostatectomy were randomly assigned to one of three groups: intravenous acetaminophen 1 g/ ibuprofen 300 mg (FDC), 1 g acetaminophen alone, or 100 mL normal saline (placebo). The intervention was administered when fascial closure was initiated. The primary outcome was moderate-to-severe grade CRBD (grade ≥3) incidence in the post-anesthesia care unit (PACU). Secondary outcomes included moderate-to-severe CRBD incidence at 1, 2, and 6 h; CRBD grade distribution; pain scores; 24-h opioid requirements; postoperative nausea and vomiting (PONV); medication-related complications; patient satisfaction; and Quality of Recovery-15K (QoR-15K) scores. Results: Overall, 172 patients were analyzed (FDC, n = 58; acetaminophen, n = 57; and placebo, n = 57). Moderate-to-severe CRBD incidence at PACU was 46.6% in the FDC group and 59.6% in both the acetaminophen and placebo groups (P = 0.3). In repeated-measures analysis, CRBD incidence decreased significantly over time across all groups. Between-group differences at individual postoperative time points were limited and not consistently reproduced across assessments. No significant differences were observed in pain score, PONV, opioid consumption, medication-related complications, patient satisfaction, or QoR-15K. Conclusions: Perioperative acetaminophen/ibuprofen FDC administration was well tolerated but did not significantly reduce moderate-to-severe CRBD incidence in the immediate postoperative period. Further studies with scheduled-dosing and investigations in other surgeries are warranted for applicability.