NCT04387617已完成2 期
Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Maximum Pain Intensity Score
研究概览
简要总结
The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.
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
- Double (Participant, Investigator)
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
- •Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution.
- •Age 18-75 years of age.
- •Patients of either gender.
- •Patients of all ethnic backgrounds.
- •Capable of giving informed consent.
- •Capable and willing to fulfill the requirements of the study.
排除标准
- •History of chronic pain.
- •Chronic use of opioid or other pain medication (> 12 weeks).
- •Known allergy to CBD oil or other cannabinoids.
- •Known or suspected pregnancy.
- •Inability to give informed consent or unable to meet requirements of the study for any reason.
- •Bilateral ureteroscopy.
- •Current marijuana, cannabidiol (CBD), or dronabinol use.
- •Liver disease/cirrhosis.
- •Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.
研究组 & 干预措施
CBD Oil Group
Experimental
干预措施: Cannabidiol (Drug)
Control Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Pain Intensity Score
时间窗: postoperative Day 3
Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.
次要结局
- Postoperative Rescue Narcotic Use(postoperative Day 3)
- Total Urinary Symptoms Score(postoperative day 1 and postoperative day 3)
- The Number of Subjects With Adverse Events(3 days post-ureteroscopy)
研究者
Karen L. Stern
Principal Investigator
Mayo Clinic
研究点 (1)
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