Potential Economic and Clinical Implications of Multi-Dose Intravenous Acetaminophen After Robotic-Assisted Prostatectomy: A Secondary Descriptive Analysis of Publicly Available Phase IV Trial Data (NCT02369211).

Introduction

This study evaluated the implications of intravenous acetaminophen (Ofirmev) on perioperative outcomes in patients undergoing robotic-assisted laparoscopic prostatectomy (RALP) for prostate cancer. The primary objective was to determine whether adding IV acetaminophen to standard analgesia could reduce hospital length of stay (LOS), pain intensity, and opioid use compared with placebo.

Methods

This study was conducted as a secondary descriptive analysis of publicly available aggregate results from a previously completed randomized, double-blind, placebo-controlled Phase IV trial (NCT02369211). No individual patient-level data were accessed, and no new independent statistical analyses were performed. Eighty-six male patients were randomly assigned to receive either 1 g IV acetaminophen or saline placebo every six hours for four doses during the perioperative period. Primary endpoints were hospital and post-anesthesia care unit (PACU) LOS; secondary endpoints included postoperative pain scores and opioid consumption (morphine milligram equivalents).

Results

Baseline characteristics were similar between groups (n = 43 each). Mean PACU stay was slightly shorter with IV acetaminophen (124 ± 58 min) than placebo (132 ± 63 min; not significant). Median hospital LOS was 0.81 days versus 0.82 days (p = 0.006), a statistically significant difference reported in the original trial dataset, although the absolute difference was clinically minimal. Pain scores and opioid requirements were lower with IV acetaminophen but not significantly different. No adverse events occurred in either group.

Conclusions

IV acetaminophen was safe and well tolerated as part of multimodal analgesia for RALP. Although pain scores and opioid use numerically favored IV acetaminophen, these differences were not statistically significant. The reported difference in hospital LOS was statistically significant in the original trial record but clinically minimal; therefore, the findings should be interpreted as exploratory and hypothesis-generating regarding potential operational and economic implications.