Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Post-operative opioid use
研究概览
简要总结
The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject capable of giving consent
- •Age 18-80
- •Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)
排除标准
- •Patient does not speak English
- •Patient with substance-use disorder (including alcohol)
- •Patient diagnosed with major depression
- •Patient currently taking opioids
- •Previous long-term opioid use (> 3 months)
- •Previous opioid use with a dose of >100 milligram morphine equivalent (MME)
- •Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
- •Documented allergy to pain medication
研究组 & 干预措施
Control
The control arm will receive no intervention and will follow standard of care for post-operative pain management.
PGx-guided
The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.
干预措施: PGx-guided post-operative pain management (Genetic)
结局指标
主要结局
Post-operative opioid use
时间窗: Post-op day 1
Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Overall Benefit of Analgesia Score (OBAS)
时间窗: Post-op day 1
次要结局
- Length of stay(30 days)
- Readmission rate(30 days)
- Functional status(4 weeks and 3 months)
研究者
David Liska
Associate Staff, Colorectal Surgery
The Cleveland Clinic