Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Condition: Prostatectomy; Pain
Study type: Interventional
Phase: Phase 4

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).
    

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.
    

Intervention name(s): Acetaminophen (Ofirmev); Placebo
Intervention type(s): Drug; Other
Intervention description(s): The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.; The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
Other intervention name(s): Ofirmev
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acetaminophen