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

September 27, 2019 updated by: Unity Health Toronto

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luana Melo, PhD
  • Phone Number: 77286 416-864-6060
  • Email: melol@smh.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
        • Contact:
          • Luana Melo, PhD
        • Principal Investigator:
          • Amit Atrey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Cannabis
Drug: Cannabidiol
Drug: Cannabinol
Postoperative pain treatment
Other Names:
  • medical cannabis
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo oral capsule
Placebo comparator
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks after total knee replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pain scale will be assessed at 24 hours, 2, 6 and 12 weeks after knee replacement
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
Questionnaire will be completed by patients at 6 weeks after knee replacement
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.
Questionnaire will be completed by patients at 6 weeks after knee replacement
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.
Questionnaire will be completed by patients at 12 weeks after knee replacement
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.
The test will be completed at 12 weeks after knee replacement
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.
Will be assessed at 12 months after knee replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT19-366965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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