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

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).

Study Overview

• Status: Completed
• Conditions: Pain; Prostatectomy
• Intervention / Treatment: Drug: Acetaminophen (Ofirmev); Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients undergoing robotic-assisted laparoscopic prostatectomy
• ≥18 years old males
• American Society of Anesthesiologists class 1-4

Exclusion Criteria:

• Chronic opiate use
• Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
• Allergy/hypersensitivity to acetaminophen
• Patients with baseline dementia
• Chronic diathesis
• Chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous acetaminophen; Patient receives 1g intravenous acetaminophen after the incision	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 Names: Ofirmev
Placebo Comparator: Placebo; Patient receives saline injection instead of the study drug	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Anesthesia Care Unit Length of Stay	The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.	approximately 30-240 min
Hospital Length of Stay	This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.	1-3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain). Mean pain score over first 24 hours postoperatively was collected.	0-24 hours after surgery
Opioid Use	A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital	0-24 hours

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Mallinckrodt
• Investigators: Principal Investigator: Richard Urman, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acetaminophen
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2014P002749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO