NCT04672252已完成2 期
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale (VAS) Score
研究概览
简要总结
This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 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
Cohort 1 - CBD
Experimental
干预措施: CBD Oral Disintegrating Tablet (ODT) (Drug)
Cohort 2 - Placebo
Placebo Comparator
干预措施: Placebo ODT (Other)
结局指标
主要结局
Pain Visual Analog Scale (VAS) Score
时间窗: Day 14 Post-Surgery
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Nausea Score on VAS Scale
时间窗: Day 14 Post-Surgery
Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
次要结局
- Number of Completed Doses Out of 3 Maximum Doses/Day(Day 14 Post-Surgery)
- Total Opioid Consumption(Day 14 Post-Surgery)
- Patient Satisfaction Score(Day 14 Post-Surgery)
研究者
研究点 (1)
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