Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
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
- 是
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
Patient receives 1g intravenous acetaminophen after the incision
干预措施: Acetaminophen (Ofirmev) (Drug)
Placebo
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
Richard D Urman
Assistant Professor of Anesthesia
Brigham and Women's Hospital
