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COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement (COPE)

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ClinicalTrials.gov Identifier: NCT03675971
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: Cannabinol Drug: Placebo oral capsule Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medical Cannabis
Drug: Cannabidiol
Drug: Cannabinol
Postoperative pain treatment
Other Name: medical cannabis

Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo oral capsule
Placebo comparator
Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Luana Melo, PhD 416-864-6060 ext 77286 melol@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Luana Melo, PhD         
Principal Investigator: Amit Atrey, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Amit Atrey, MD St. Michael's Hospital, Toronto

Publications:
Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2016-2017: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2018

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03675971     History of Changes
Other Study ID Numbers: RCT19-366965
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by St. Michael's Hospital, Toronto:
Pain Management; Analgesics, Opioid; Cannabis