COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
试验速览
- 阶段
- 2 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery.
Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction.
Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief.
This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.
详细描述
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.
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
- Triple (Participant, 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
- •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
排除标准
- •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
研究组 & 干预措施
Medical Cannabis
Drug: Cannabidiol
干预措施: Cannabinol (Drug)
Placebo
Placebo comparator
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 2 weeks after total knee replacement
Assess cumulative opioid consumption (morphine equivalent dose) by means of drug reconciliation (medication diaries and pill counts) i.e. patients will self report how many opioid pills they took each day, by means of the medication diaries and at 4 weeks follow up will bring the pills back to clinic appointment.
次要结局
- Visual Analog Pain Scale(Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement)
- Oxford knee score(Questionnaire will be completed by patients at 6 weeks after knee replacement)
- Self-reported opioid use and urinalysis(The test will be completed at 12 weeks after knee replacement)
- Health status and quality of life(Questionnaire will be completed by patients at 6 weeks after knee replacement)
- Quality of recovery - 15 (QoR-15)(Questionnaire will be completed by patients at 12 weeks after knee replacement)
- Narcotic monitoring prescription(Will be assessed at 12 months after knee replacement)