NCT05240755已完成早期 1 期
Effectiveness of Cannabidiol Vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Requiring shoulder arthroscopic surgery for soft tissue pathology
- •Able to complete surveys and follow-up visits
排除标准
- •Younger than 18 years of age
- •Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.
研究组 & 干预措施
Cannabidiol Oil 100 mg
Experimental
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
干预措施: Cannabidiol Oil (Drug)
Cannabidiol Oil 200 mg
Experimental
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
干预措施: Cannabidiol Oil (Drug)
结局指标
主要结局
Post-operative pain
时间窗: 30 days post-operatively
Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.
次要结局
- Sleep Quality(30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.)
研究者
Michael C. Doarn
Principal Investigator, Clinical Professor of Orthopaedic Surgery - USF
Foundation for Orthopaedic Research and Education
研究点 (1)
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