COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Nabilone

Criteria

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