National Institute of Arthritis and Musculoskeletal and Skin Diseases 11192350

Cannabidiol for postoperative Opioid Reduction in primary total Knee arthroplasty – a randomized, 2x2 factorial, double-blind, placebo-controlled clinical trial (The CORK trial)

This award funds a clinical trial to evaluate the effectiveness of cannabidiol (CBD) in reducing opioid use and related symptoms after knee surgery. It is a randomized, double-blind, placebo-controlled study involving 380 patients.

Description

The project aims to assess whether perioperative CBD reduces opioid consumption after surgery, as well as pain, anxiety, sleep disturbance, and inflammation. The study involves recruiting 380 patients undergoing primary total knee arthroplasty from two large health systems. The primary outcome is post-operative opioid consumption in the 4-week period following surgery. The study design is a multi-site, 2x2 factorial, double-blind, randomized controlled trial. The study drug is CBD (300 mg/day), and the control is placebo. The study will also investigate CBD's effects on anxiety, sleep disturbance, inflammation, side effects, adverse events, and pharmacokinetics. The findings could have broader implications beyond TKA and motivate further research into the role of CBD.

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