关节镜手术后屈大麻酚
屈大麻酚治疗关节镜手术后疼痛的随机试验
The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Feinberg School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Age 18 years or older
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Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
- Meniscectomy
- Synovectomy
- Chondroplasty
- Loose body removal
Exclusion Criteria:
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Patients under age 18 years
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Patients who cannot provide consent
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Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
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Patients with an allergy to any of the study drugs
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Patient who are lactose-intolerant
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Revision surgery
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Open surgery
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Comorbidities preventing surgery
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Patients with a history of mania, depression, or schizophrenia
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Patients taking any of the following drugs or supplements
- Anticholinergic agents
- Benzodiazepines
- Central nervous system depressants
- Droperidol
- Hydroxyzine
- Levomepromazine or methotrimeprazine
- Monoamine oxidase inhibitors
- Ritonavir
- Selective serotonin reuptake inhibitors
- Sympathomimetics
- St. John's Wort
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Current diagnosed alcohol or drug abuse
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Patients who cannot or will not abide by the medication restrictions listed below
Medication restrictions
- Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period
- Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dronabinol
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
5mg 2x daily for 7 days
其他名称：
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|
安慰剂比较：Placebo
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
1 caplet 2x daily for 7 days |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Opioid consumption
大体时间：up to 7 days post-surgery
|
Count of number of hydrocodone/acetaminophen tablet consumed |
up to 7 days post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Visual Analog Scale (VAS)
大体时间：up to 7 days post-surgery
|
Scored from 0 (no pain) to 10 (worst possible pain) |
up to 7 days post-surgery
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
大体时间：up to 21 days post-surgery
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PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome). |
up to 21 days post-surgery
|
|
PROMIS Bank v2.0 - Pain Behavior
大体时间：up to 21 days post-surgery
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PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome). |
up to 21 days post-surgery
|
|
PROMIS Bank v2.0 - Physical Function
大体时间：up to 21 days post-surgery
|
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning. |
up to 21 days post-surgery
|
合作者和调查者
调查人员
- 首席研究员：Vehniah K Tjong, MD、Northwestern Feinberg School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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