Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT
Status:
Not yet recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Each year, approximately 67,000 Canadians undergo knee replacement surgery, and up to 20%
develop persistent post-surgical pain. Persistent post-surgical pain is associated with
depression, anxiety, unemployment, and reduced quality of life. Chronic pain after surgery is
often managed with opioid therapy, which typically provides only modest benefits and is
associated with rare but serious adverse events, such as overdose and death. A number of
studies have found that greater pain just before and after knee replacement surgery is
associated with the development of chronic pain, suggesting that reducing peri-operative pain
may help prevent persistent post-surgical pain.
Medicinal cannabis has begun to emerge as a potential therapy for pain reduction, and
produces effects largely due to 2 active components: (1) cannabidiol (CBD), and (2)
tetrahydrocannabinol (THC). Studies of CBD have shown analgesic, anti-inflammatory, and
anti-anxiety properties, but without the psychoactive effects (feeling 'high') that THC
produces. This study will assess the feasibility of a definitive trial to explore whether
adding CBD vs. placebo to usual care before and after surgery can reduce the rate of
persistent post-surgical pain after total knee replacement. This study will randomize 40
patients to receive either CBD or placebo, and follow them for six months to confirm our
ability to recruit patients, adhere to protocol, and capture full outcome data for at least
90% of patients.
Phase:
Phase 3
Details
Lead Sponsor:
McMaster University
Collaborators:
Hamilton Health Sciences Corporation Michael G. DeGroote Centre for Medicinal Cannabis Research Michael G. DeGroote National Pain Centre St. Joseph's Healthcare Hamilton