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

Phase 4

Completed

Conditions: Pain
Prostatectomy

Interventions: Other: Placebo
Drug: Acetaminophen (Ofirmev)

Registration Number: NCT02369211

Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 86

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patient receives saline injection instead of the study drug
Intravenous acetaminophen	Acetaminophen (Ofirmev)	Patient receives 1g intravenous acetaminophen after the incision

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain Score	0-24 hours after surgery	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.
Opioid Use	0-24 hours	A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital