Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty - a Randomized, Two by Two Factorial, Double-blind, Placebo-controlled Clinical Trial
The goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery. The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.
• Willing and able to read, understand, and sign the informed consent (English)
• Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up
• Scheduled for surgery: primary total knee arthroplasty
• Primary diagnosis of osteoarthritis of the surgical knee
• Individuals of reproductive potential must agree to use acceptable birth control (defined in manual of operating procedures). This includes currently practicing an effective form of two types of birth control for women of childbearing potential, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly from the screening visit until 28 days after the last study drug administration.
• Participants must also agree not to donate sperm or eggs during study drug administration
• Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen
• Agreement to adhere to Lifestyle Considerations (see protocol) throughout study duration