Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months - A Pilot Trial.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries
排除标准
- •BMI greater than 40
研究组 & 干预措施
Postoperative methadone
干预措施: Postoperative methadone (Drug)
Postoperative methadone
干预措施: Rescue Analgesia (Drug)
Postoperative placebo
干预措施: Postoperative placebo (Drug)
Postoperative placebo
干预措施: Rescue Analgesia (Drug)
结局指标
主要结局
Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described
时间窗: Day of discharge (about 6 days after surgery)
Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)
时间窗: postop days 1 and 5
Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)
时间窗: Day of discharge (about 6 days after surgery)
ability to evaluate adverse respiratory events
Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months
时间窗: 3 months after surgery
次要结局
- Safety as assessed by the number of participants with dizziness(by fifth day of hospital stay)
- Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation(by fifth day of hospital stay)
- Safety as assessed by the number of participants with occurrence of nausea(by fifth day of hospital stay)
- Number of participants for which opioid usage was able to be collected(Day of discharge (about 6 days after surgery))
- Safety as assessed by the number of participants with hallucinations(by fifth day of hospital stay)
- Safety as assessed by the number of participants with Antiemetic use(by fifth day of hospital stay)
- Safety as assessed by the number of participants with occurrence of vomiting(by fifth day of hospital stay)
- Safety as assessed by the number of patients developing respiratory depression(by fifth day of hospital stay)
- Safety as assessed by the number of subjects with persistent opioid use(3 months after surgery)
- Safety as assessed by the number of participants with occurrence of Ileus or constipation(by fifth day of hospital stay)
研究者
Shobana Rajan
Associate Professor
The University of Texas Health Science Center, Houston