NCT02369211

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 11, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

February 17, 2015

Results QC Date

August 3, 2019

Last Update Submit

September 10, 2019

Conditions

ProstatectomyPain

Keywords

acetaminophen

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Pain Score

    0-24 hours after surgery

  • Opioid Use

    0-24 hours

Study Arms (2)

Intravenous acetaminophen

EXPERIMENTAL

Patient receives 1g intravenous acetaminophen after the incision

Drug: Acetaminophen (Ofirmev)

Placebo

PLACEBO COMPARATOR

Patient receives saline injection instead of the study drug

Other: Placebo

Interventions

Acetaminophen (Ofirmev)DRUG

The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.

Also known as: Ofirmev
Intravenous acetaminophen
PlaceboOTHER

The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
James Webber
Organization
Brigham and Women's Hospital
jwebber1@partners.org
(617) 732-6877

Study Officials

  • Richard Urman, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 23, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

September 11, 2019

Results First Posted

September 11, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)