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临床试验/NCT02369211
NCT02369211已完成4 期

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
86
试验地点
1
主要终点
Post Anesthesia Care Unit Length of Stay

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Intravenous acetaminophen

Experimental

Patient receives 1g intravenous acetaminophen after the incision

干预措施: Acetaminophen (Ofirmev) (Drug)

Placebo

Placebo Comparator

Patient receives saline injection instead of the study drug

干预措施: Placebo (Other)

结局指标

主要结局

Post Anesthesia Care Unit Length of Stay

时间窗: 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

时间窗: 1-3 days

This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.

次要结局

  • Pain Score(0-24 hours after surgery)
  • Opioid Use(0-24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard D Urman

Assistant Professor of Anesthesia

Brigham and Women's Hospital

研究点 (1)

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