Investigating the Effect of Dronabinol on Post-surgical Pain
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory-Short Form
研究概览
简要总结
This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).
详细描述
Total knee replacement is a common surgical procedure that restores function to the damaged joint. Recovery from this procedure takes weeks and requires opioids to manage post-surgical pain. The goal of this study is to investigate whether dronabinol (synthetic THC) can reduce pain and the need for opioid medication following this particular surgery.
Subjects will be recruited from the Department of Orthopedic Surgery. All subjects will undergo total knee replacement as part of their clinical care (the surgery itself is not part of this study). The study begins following discharge from the hospital. They will be asked to take dronabinol or placebo as they recover from surgery. During this time they will be given their usual pain medications at discharge which includes opioids for pain. The opioids are to be taken if the subject is experiencing pain. The investigator's hypothesis is that subjects taking dronabinol will need fewer doses of opioids to control 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants undergoing total knee arthroplasty (TKA) at the CUIMC department of orthopedic surgery as part of their clinical care.
- •Able to give informed consent and comply with study procedures in English
排除标准
- •Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. Subjects with a current substance use disorder will be excluded. Subjects with a past cannabis use disorder are excluded.
- •Diagnosis of a major medical or neurological disorder, including orthostatic hypertension, cardiovascular disease (congestive heart failure, unstable angina, or a history of cardiac infarction), hypotension, or neurodegenerative disorders.
- •Subjects taking medications that can lead to a drug interaction.
研究组 & 干预措施
dronabinol
active group
干预措施: Dronabinol 5mg Cap (Drug)
dronabinol
active group
干预措施: Non-active comparator (Drug)
control
control group
干预措施: Dronabinol 5mg Cap (Drug)
control
control group
干预措施: Non-active comparator (Drug)
结局指标
主要结局
Brief Pain Inventory-Short Form
时间窗: 2 weeks
pain assessment, self report measure of pain, scale 0-10 (10 worst)
次要结局
- opioid medication log(two weeks)
研究者
Diana Martinez
Psychiatrist II
New York State Psychiatric Institute