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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02369211
• Collaborator: Mallinckrodt (Industry)
• Enrollment: 86
• Location: 1
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. Opioid Use [0-24 hours]

   A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• Mallinckrodt

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 16, 2015

More Information

Publications

None provided.

• Responsible Party: Richard D Urman, Assistant Professor of Anesthesia, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02369211
• Other Study ID Numbers: 2014P002749
• First Posted: Feb 23, 2015
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Richard D Urman, Assistant Professor of Anesthesia, Brigham and Women's Hospital: acetaminophen
• Additional relevant MeSH terms: Acetaminophen

Study Results

Participant Flow

Recruitment Details	Patients were recruited in the preoperative assessment clinic prior to undergoing surgery

Arm/Group Title	Intravenous Acetaminophen	Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo
Period Title: Overall Study
STARTED	43	43
COMPLETED	43	41
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Intravenous Acetaminophen	Placebo	Total
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo	Total of all reporting groups
Overall Participants	43	41	84
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 32.6%	16 39%	30 35.7%
>=65 years	29 67.4%	25 61%	54 64.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.6 (6.1)	60.2 (6.3)	61.7 (6.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	43 100%	41 100%	84 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	43 100%	41 100%	84 100%

Outcome Measures

1. Primary Outcome

Title	Post Anesthesia Care Unit Length of Stay
Description	The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
Time Frame	approximately 30-240 min

Outcome Measure Data

Analysis Population Description

Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery.

Arm/Group Title	Intravenous Acetaminophen	Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo
Measure Participants	34	41
Mean (Standard Deviation) [minutes]	124 (58.26)	132 (62.58)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay.

Arm/Group Title	Intravenous Acetaminophen	Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo
Measure Participants	34	41
Median (95% Confidence Interval) [Days]	0.81	0.82

3. Secondary Outcome

Title	Pain Score
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.
Time Frame	0-24 hours after surgery

Outcome Measure Data

Analysis Population Description

Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms.

Arm/Group Title	Intravenous Acetaminophen	Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo
Measure Participants	41	43
Mean (Inter-Quartile Range) [score on a scale]	0.62	0.88

4. Secondary Outcome

Title	Opioid Use
Description	A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

Patients who underwent surgery and stayed in the hospital as inpatients and received pain management.

Arm/Group Title	Intravenous Acetaminophen	Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Patient receives saline injection instead of the study drug Placebo
Measure Participants	43	41
Median (Inter-Quartile Range) [morphine milligram equivalents]	42	50

Adverse Events

Time Frame	Patients were followed for 30 days after surgery for which adverse events were collected.
Adverse Event Reporting Description	Same definition of adverse event was used.
Arm/Group Title	Intravenous Acetaminophen		Placebo
Arm/Group Description	Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)		Patient receives saline injection instead of the study drug Placebo
All Cause Mortality
	Intravenous Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/41 (0%)
Serious Adverse Events
	Intravenous Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Intravenous Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.