COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
关键词
抽象
描述
COPE (Cannabinoids to Obviate Pain Experiment after knee replacement) will be a single-centre, prospective, randomized, placebo-controlled, superiority trial, with two parallel groups designed to investigate the effect of cannabis as postoperative pain treatment compared to placebo on total opioid consumption after total knee replacement.
Eligible patients are: men and non-pregnant women aged ≥18 years scheduled to undergo primary total knee replacement. and with no opioid usage within the last 3 months or history of narcotic abuse.
Patients will be recruited at the department of orthopaedic surgery at St Michael's Hospital (Toronto - Canada), and informed consent will be obtained from those eligible. Central computer-generated randomization will be used to randomly assign participants to cannabis or placebo groups (1:1 ratio). Only the study pharmacist will know allocated treatments.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 08/27/2018 |
| 提交的预估入学人数: | 09/16/2018 |
| 首次发布: | 09/17/2018 |
| 上次提交的更新: | 09/26/2019 |
| 最近更新发布: | 09/30/2019 |
| 实际学习开始日期: | 04/30/2020 |
| 预计主要完成日期: | 05/14/2021 |
| 预计完成日期: | 04/30/2022 |
状况或疾病
干预/治疗
Drug: Medical Cannabis
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Medical Cannabis Drug: Cannabidiol | Drug: Medical Cannabis Postoperative pain treatment |
| Placebo Comparator: Placebo Placebo comparator | Drug: Placebo Placebo comparator |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 18 years of age and older - Men and women - Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement - Patients undergoing primary unilateral total knee replacement - Patient is able to provide informed consent to participation in the study Exclusion Criteria: - Pregnancy - Breastfeeding - Current opioid use - Cognitive impairment or mental illness (e.g., dementia, Alzheimer disease and psychoses), which will prevent patients from reliably providing primary outcome data - Unable to swallow an oral tablet (medication) - History of opiate, narcotic and alcohol abuse - Revision total knee replacement surgery - High risk of falls as determined by the treating physician - Patients refusing participation - Pre-existing/ regular cannabis use |
结果
主要结果指标
1. Opioid consumption [2 weeks after total knee replacement]
次要成果指标
1. Visual Analog Pain Scale [Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement]
2. Oxford knee score [Questionnaire will be completed by patients at 6 weeks after knee replacement]
3. Health status and quality of life [Questionnaire will be completed by patients at 6 weeks after knee replacement]
4. Quality of recovery - 15 (QoR-15) [Questionnaire will be completed by patients at 12 weeks after knee replacement]
5. Self-reported opioid use and urinalysis [The test will be completed at 12 weeks after knee replacement]
6. Narcotic monitoring prescription [Will be assessed at 12 months after knee replacement]
