COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement (COPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03675971|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Drug: Cannabinol Drug: Placebo oral capsule||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||May 15, 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Medical Cannabis
Postoperative pain treatment
Other Name: medical cannabis
Placebo Comparator: Placebo
Drug: Placebo oral capsule
Other Name: Placebo
- Opioid consumption [ Time Frame: 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.
- Visual Analog Pain Scale [ Time Frame: Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement ]Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
- Oxford knee score [ Time Frame: Questionnaire will be completed by patients at 6 weeks after knee replacement ]A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after knee replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
- Health status and quality of life [ Time Frame: Questionnaire will be completed by patients at 6 weeks after knee replacement ]EQ-5D is a questionnaire where patients self-rate their level of severity of health status and health-related quality of life. Consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
- Quality of recovery - 15 (QoR-15) [ Time Frame: Questionnaire will be completed by patients at 12 weeks after knee replacement ]Quality of recovery scores are patient-reported outcome measures evaluating recovery after surgery regarding the last 24h. It is a short-form score with 15 questions that assess the 5 dimensions (pain, physical comfort, physical independence, physiological support and emotional state) and has 2 parts (A and B). Part A scores from 0 [poor] to 10 [excellent] - as higher is the score as better is the recovery. Part B scores from 10 [excellent] to 0 [poor] - as higher is the score as better is the recovery.
- Self-reported opioid use and urinalysis [ Time Frame: The test will be completed at 12 weeks after knee replacement ]Patients will self report whether they are still using opioids (yes or no) and they will undergo a urinalysis (urine test). Patients will pee in a designed cup and a trained assessed will test the urine (with chemical strip) to detect the presence of one or more opioids in urine.
- Narcotic monitoring prescription [ Time Frame: Will be assessed at 12 months after knee replacement ]Using data from the Narcotics Monitoring System from ICES (Institute for Clinical Evaluative Sciences) which already captures all opioid prescriptions dispensed in retail pharmacies across Ontario, the investigators will assess if participants have had any filled prescription after knee replacement and record the number of prescriptions filled.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675971
|Contact: Luana Melo, PhD||416-864-6060 ext email@example.com|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Luana Melo, PhD|
|Principal Investigator: Amit Atrey, MD|
|Principal Investigator:||Amit Atrey, MD||St. Michael's Hospital, Toronto|