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

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ClinicalTrials.gov Identifier: NCT02369211
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Richard D Urman, 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).

Condition or disease Intervention/treatment Phase
Prostatectomy Pain Drug: Acetaminophen (Ofirmev) Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
Actual Study Start Date : September 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Post Anesthesia Care Unit Length of Stay [ Time Frame: approximately 30-240 min ]
    The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.

  2. Hospital Length of Stay [ Time Frame: 1-3 days ]
    This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 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.


  2. Opioid Use [ Time Frame: 0-24 hours ]
    A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369211


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Mallinckrodt
Investigators
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Principal Investigator: Richard Urman, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Richard D Urman, Brigham and Women's Hospital:

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Responsible Party: Richard D Urman, Assistant Professor of Anesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02369211     History of Changes
Other Study ID Numbers: 2014P002749
First Posted: February 23, 2015    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard D Urman, Brigham and Women's Hospital:
acetaminophen
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics