Expired Study
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Boston, Massachusetts 02115


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

2014P002749


NCT ID:

NCT02369211


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

86


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard Urman, MD
Principal Investigator
Brigham and Women's Hospital

Study Dates

Start Date:September 2015
Completion Date:March 2018
Completion Type:Actual
Primary Completion Date:January 2018
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 10, 2019
First Received Date:February 17, 2015
First Results Date:August 3, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Post Anesthesia Care Unit Length of Stay
Time Frame:approximately 30-240 min
Safety Issues:False
Description:The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
Outcome Type:Primary Outcome
Measure:Hospital Length of Stay
Time Frame:1-3 days
Safety Issues:False
Description:This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
Outcome Type:Secondary Outcome
Measure:Pain Score
Time Frame:0-24 hours after surgery
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Opioid Use
Time Frame:0-24 hours
Safety Issues:False
Description:A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital

Study Interventions

Intervention Type:Drug
Name:Acetaminophen (Ofirmev)
Description:The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
Arm Name:Intravenous acetaminophen
Other Name:Ofirmev
Intervention Type:Other
Name:Placebo
Description:The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Intravenous acetaminophen
Description:Patient receives 1g intravenous acetaminophen after the incision
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Patient receives saline injection instead of the study drug

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Mallinckrodt

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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