NCT02369211

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its potential to improve hospital efficiency and patient outcomes. The investigators compare the addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of opiates as rescue agents and side effects among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).

Detailed description

Although IV acetaminophen has been studied in urologic surgery, it has not been studied specifically in prostatectomies, and therefore there are no outcomes or cost-effectiveness data currently available. In addition, the current trend is to perform prostatectomy with a robot-assisted laparoscopic technique to help minimize incision size, blood loss, postoperative pain, and speed up patient recovery. Current literature only includes the use of opioids in the perioperative setting for robot-assisted prostatectomy to treat pain, but only a small trial used oral acetaminophen as a measure for analgesia in RALP. In addition to the decreasing use of opioids in perioperative pain management, emphasis has been placed on reducing costs of healthcare. A major contributor to this issue is hospital length of stay (LOS) and there has been increased pressure on healthcare providers to decrease overall LOS. Several factors may contribute to hospital LOS, including hospital acquired infections, surgical recovery, wound care, other surgical and anesthesia-related complications, and importantly, inadequate pain control. In this study we examine the impact of adding IV acetaminophen to the multimodal analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP). Our hypothesis is that the addition of IV acetaminophen can improve postoperative recovery time, inpatient LOS, postoperative pain scores, and opioid consumption. This study specifically addresses pharmacoeconomics of IV acetaminophen. The goal is to understand its potential to improve hospital efficiency and patient outcomes. The study compares the impact of the addition of IV acetaminophen versus a placebo on postoperative anesthesia care unit recovery times, inpatient LOS, postoperative pain scores, consumption of opiates as rescue agents and side effects in patients undergoing RALP. The study is a 2-arm, double-blind, randomized, placebo controlled trial comparing IV acetaminophen to a control (IV placebo). All patients in this study were scheduled to undergo RALP.

Conditions

• Prostatectomy
• Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen (Ofirmev)	The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
OTHER	Placebo	The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-01-01
• Completion: 2018-03-01
• First posted: 2015-02-23
• Last updated: 2019-09-11
• Results posted: 2019-09-11

Locations

1 site across 1 country: United States