Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Opioid consumption
研究概览
简要总结
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
- •Meniscectomy
- •Synovectomy
- •Chondroplasty
- •Loose body removal
排除标准
- •Patients under age 18 years
- •Patients who cannot provide consent
- •Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
- •Patients with an allergy to any of the study drugs
- •Patient who are lactose-intolerant
- •Revision surgery
- •Open surgery
- •Comorbidities preventing surgery
- •Patients with a history of mania, depression, or schizophrenia
- •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
- •Current diagnosed alcohol or drug abuse
- •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
研究组 & 干预措施
Placebo
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
干预措施: Placebo (Drug)
Dronabinol
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
干预措施: Dronabinol (Drug)
结局指标
主要结局
Opioid consumption
时间窗: up to 7 days post-surgery
Count of number of hydrocodone/acetaminophen tablet consumed
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference(up to 21 days post-surgery)
- Pain Visual Analog Scale (VAS)(up to 7 days post-surgery)
- PROMIS Bank v2.0 - Pain Behavior(up to 21 days post-surgery)
- PROMIS Bank v2.0 - Physical Function(up to 21 days post-surgery)
研究者
Vehniah Tjong
Assistant Professor
Northwestern University