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
|Condition or disease||Intervention/treatment||Phase|
|Prostatectomy Pain||Drug: Acetaminophen (Ofirmev) Other: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
- 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.
- 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.
- 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.
- 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
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
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Richard Urman, MD||Brigham and Women's Hospital|