Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 907
- 试验地点
- 1
- 主要终点
- Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)
研究概览
简要总结
The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).
详细描述
This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day discharge surgery (compare short-duration vs long-duration opioid).
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
干预措施: Hydromorphone (Drug)
Short-stay, IV methadone
Anticipated next-day discharge; intraoperative and post-operative IV methadone
干预措施: Methadone (Drug)
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
干预措施: Fentanyl (Drug)
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
干预措施: Hydromorphone (Drug)
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
干预措施: Morphine (Drug)
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
干预措施: Sufentanil (Drug)
Same-day, IV methadone
Intraoperative and post-operative IV methadone
干预措施: Methadone (Drug)
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
干预措施: Fentanyl (Drug)
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
干预措施: Morphine (Drug)
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
干预措施: Sufentanil (Drug)
结局指标
主要结局
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)
时间窗: Approximately 30 days
Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects.
次要结局
- Total Intraoperative Non-methadone Opioid Administration(Approximately 12 hours)
- Total Post Anesthesia Care Unit (PACU) Opioid Administration(Approximately 2 hours)
- Total Hospital Non-methadone Opioid Administration(Start of surgery to hospital discharge, up to 2 days)
- Total 7-day Post-PACU Discharge Home Opioid Use(Up to 7 days post-PACU discharge)