A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Intravenous Acetaminophen Versus Placebo in Patients Undergoing Robotic-Assisted Laparoscopic Prostatectomy

Abstract

Radical prostatectomy for prostate cancer is one of the most commonly performed operations in men. The objective of this study was to determine the impact of intravenous (IV) acetaminophen when added to the perioperative analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP) on hospital length of stay (LOS), postoperative pain scores, and opioid consumption. In this prospective, randomized, double-blind, placebo-controlled trial, a total of 86 patients undergoing RALP were prospectively enrolled and randomly assigned to receive either 1 g IV acetaminophen (study group; n = 43) or IV placebo (n = 43) within 15 minutes following the induction of anesthesia and prior to surgical incision. Seventy-five records were completed and included for analysis. Pain scores were recorded every 30 minutes for 2 hours in the postanesthesia care unit (PACU) and then 16 distinct time points for 48 hours after PACU discharge. Repeat doses of IV acetaminophen or placebo was given every 6 hours for a total of four doses. Median average pain scores after PACU discharge between the treatment and placebo groups were 0.62 vs. 0.88, respectively (P = .055), over the first 24 hours and 1.28 vs. 2.25, respectively (P = .13), over the second 24 hours. Hospital LOS was shorter in the IV acetaminophen group compared with placebo by 32% (P = .006). Median intraoperative opioid use in the IV acetaminophen group was 42 mg morphine equivalents compared with 50 mg in placebo (P = .64) and 8 mg in both groups postoperatively (P = .16). Overall, use of perioperative IV acetaminophen decreased hospital LOS without a significant difference in PACU LOS, pain scores, or opioid use.

Keywords:

• Acetaminophen
• analgesia
• intravenous
• opioids
• outcome
• pain
• pharmacoeconomics
• surgery

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.

Additional information

Funding

This study was funded by an investigator-initiated grant from Mallinckrodt, Inc.