Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Total Opioid Dose (MME) Used in 24 Hours
研究概览
简要总结
The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years old
- •Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
- •Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).
排除标准
- •Age younger than 18 years old or older than 90 years old
- •Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases)
- •Weight less than 50 kg
- •Epidural use
- •History of known liver disease.
- •Patient unable to take enteral medications.
- •Be taking opioid medications chronically.
研究组 & 干预措施
placebo IV (normal saline) + oral acetaminophen
干预措施: Acetaminophen (Drug)
IV acetaminophen and placebo pills
干预措施: Acetaminophen (Drug)
IV acetaminophen and placebo pills
干预措施: Placebo Oral Tablet (Drug)
placebo IV (normal saline) + oral acetaminophen
干预措施: Placebos (Drug)
结局指标
主要结局
Total Opioid Dose (MME) Used in 24 Hours
时间窗: 20 to 24 hours post-operatively
Total opiate dose used from the study start (when the first dose of acetaminophen is administered in the pre-anesthesia holding area) to 24 hours post-operatively (in morphine milligram equivalents (MME)).This will include opiates administered intra-operatively.
次要结局
- Average Surgical Pain Intensity(1-2 hours post-operatively)
- Mean Inspiratory Capacity(20-24 hours post-operatively)
- Dynamic Pain Score During Incentive Spirometer Use(20-24 hours post-operatively)
- Surgical Pain Score During the 20-24 Hour Assessment(20-24 hours post-operatively)
- Time to First Narcotic Use(24 hours post-operatively)
- Number of Participants With Nausea(24 hours post-operatively)
- Time to Discharge From Post-anesthesia Care Unit(24 hours)
- Time to Hospital Discharge(30 days)
研究者
Joseph W Dooley, MD
Associate Professor
University of Rochester