Clinical trial NCT03675971: COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
Official title: COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Arthroplasty, Replacement, Knee
Keywords: Pain Management; Analgesics, Opioid; Cannabis
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Opioid consumption
timeFrame: 2 weeks after total knee replacement
Secondary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement
measure: Oxford knee score
timeFrame: Questionnaire will be completed by patients at 6 weeks after knee replacement
measure: Health status and quality of life
timeFrame: Questionnaire will be completed by patients at 6 weeks after knee replacement
measure: Quality of recovery - 15 (QoR-15)
timeFrame: Questionnaire will be completed by patients at 12 weeks after knee replacement
measure: Self-reported opioid use and urinalysis
timeFrame: The test will be completed at 12 weeks after knee replacement
measure: Narcotic monitoring prescription
timeFrame: Will be assessed at 12 months after knee replacement
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Amit Atrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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