The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Score on Pain Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is 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, 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 undergoing an ankle fracture open reduction and internal fixation (medial malleolus, lateral malleolus, posterior malleolus, and/or syndesmosis repair), tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation and intramedullary nail fixation), or tibial plateau open reduction and internal fixation
- •Patients ages 18-75, inclusive
- •Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
- •Male patients must be using an effective form of contraception
排除标准
- •Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
- •Younger than 18 years of age
- •Older than 75 years of age
- •Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
- •History of cannabis abuse or dependence
- •History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
- •History of stroke or acute coronary syndromes within 3 months before surgery
- •Abnormal coagulation profile
- •Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
- •Patients that have been on pre-operative opioid management for any reason
- •Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
- •Patients diagnosed with major depression, psychosis, or substance abuse disorder
- •Patients with current or a history of suicidal ideation
- •Breastfeeding females
- •Patients with clinically significant illness, including cardiovascular disorders
- •Clinically significant lab abnormalities
- •Abnormal LFTs
- •Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
- •Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
- •Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 concomitantly
- •Patients taking strong CYP3A4 and CYP2C19 inducers concomitantly
研究组 & 干预措施
Cannabidiol (CBD)
干预措施: CBD (Drug)
Control
干预措施: Placebo (Drug)
结局指标
主要结局
Score on Pain Visual Analog Scale (VAS)
时间窗: Day 14 Post-Surgery
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Level of Nausea Using VAS
时间窗: Day 14 Post-Surgery
Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)
次要结局
- Opioid Consumption(Day 14 Post-Surgery)
- CBD Consumption(Day 14 Post-Surgery)
- Patient Satisfaction Score(Day 14 Post-Surgery)