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临床试验/NCT05934500
NCT05934500尚未招募早期 1 期

Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery

Foundation for Orthopaedic Research and Education1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Post-operative pain control

研究概览

简要总结

This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

详细描述

This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.

All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
  • able to complete surveys and follow-up visits

排除标准

  • younger than 18 years of age
  • history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, *pregnancy.

研究组 & 干预措施

Cannabidiol Oil 100 mg/day

Experimental

CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively

干预措施: Cannabidiol Oil (Drug)

Cannabidiol Oil 200 mg/day

Experimental

CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.

干预措施: Cannabidiol Oil (Drug)

结局指标

主要结局

Post-operative pain control

时间窗: 30 days post-operatively

Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.

次要结局

  • Sleep Quality(30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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