COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
NCT03675971 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2019-10-01
Summary
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.
Conditions
- Arthroplasty, Replacement, Knee
Interventions
- DRUG
-
Cannabinol
Postoperative pain treatment
- DRUG
-
Placebo oral capsule
Placebo comparator
Sponsors & Collaborators
-
Unity Health Toronto
lead OTHER
Principal Investigators
-
Amit Atrey, MD · Unity Health Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-01
- Primary Completion
- 2021-05-15
- Completion
- 2022-05-31
Countries
- Canada
Study Locations
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