Status:
COMPLETED
Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Each year, approximately 75,000 Canadians undergo knee replacement surgery, and up to 25% develop persistent post-surgical pain. Persistent post-surgical pain is associated with depression, anxiety, u...
Detailed Description
Approximately 25% of patients develop persistent post-surgical pain (PPSP) after undergoing total knee arthroplasty (TKA), and higher pre-surgery and acute post-operative pain are associated with this...
Eligibility Criteria
Inclusion
- Patients undergoing TKA aged 18 or older
- Cognitive ability and English-language skills required to complete outcome measures
- Provision of informed consent
- Successful completion of the run-in period
Exclusion
- Severe cardio-respiratory disease (For operationalizing: ASA 4/NYHA 4)
- Substance use disorder based on DSM-V criteria
- Allergy or intolerance to cannabis, cannabis derivatives, or other ingredients of the study drug
- Patients who are pregnant, planning to be pregnant, or breastfeeding
- Revision TKA
- Bilateral TKA
- Presenting for their pre-surgical consultation less than 4 weeks before surgery
- Patients with a chronic pain condition affecting the knee (other than osteoarthritis) (e.g.: patients with knee pain due to fibromyalgia or chronic pain syndrome will be excluded)
- Unwilling or unable to follow the study protocol
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03825965
Start Date
May 3 2023
End Date
February 25 2025
Last Update
March 19 2025
Active Locations (2)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8