Pain Clinical Trial
Official title:
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
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).
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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