NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of Opioid Use in Postoperative Period
研究概览
简要总结
The purpose of this study is to see how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in participants after robotic-assisted partial nephrectomy.
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
- Double (Care Provider, Investigator)
盲法说明
After study recruitment, the patient will be randomized to the NSAID group (group 1) vs. the no-NSAID group (group 2). Randomization will be masked until after the renorrhaphy is completed and the surgical team will administer versus not administer ketorolac based on group assignment.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Allergy to NSAIDs
- •Myocardial infarction or unstable angina within 12 months.
- •Any history of coronary artery bypass graft surgery.
- •History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. Glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
- •Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
- •Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
- •Solitary kidney.
- •Pregnancy.
- •Inability to give informed consent or unable to meet requirement of the study for any reason.
研究组 & 干预措施
Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Ketorolac (Drug)
Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Acetaminophen (Drug)
Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Oxycodone (Drug)
Group 2: No-NSAID
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Acetaminophen (Drug)
Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Hydromorphone (Drug)
Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Ibuprofen (Drug)
Group 2: No-NSAID
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Oxycodone (Drug)
Group 2: No-NSAID
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Rate of Opioid Use in Postoperative Period
时间窗: Up to 20 days
Rate of opioid use is defined as the number of participants who used opioid medications during the post-operative period (defined as end of surgery to post-operative follow up visit) divided by total number of participants in the group at postoperative visit.
次要结局
- Rate of Opioid Medication Use during Hospitalization(Up to 24 hours)
- Pain Score Assessed by Standardized Script(Up to 20 days)
- Pain Score Assessed by International Pain Outcome Questionnaire(Up to 20 days)
- Number of Treatment-Related Adverse Events(Up to 20 days)
- Change in Rate of Acute Kidney Injury(Baseline, Up to 20 days)
研究者
Mark L. Gonzalgo, MD, PhD
Professor of Clinical
University of Miami