drugset / Trial / NCT04749628

Cannabidiol for Bilateral Total Knee Arthroplasty

NCT04749628

Phase 4 Completed 37 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupTriple-blindTreatment

Summary

In light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future RCTs examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. Epidiolex®, an oral cannabidiol (CBD) solution, is the first ever cannabis-derived medication to be approved by the Food \& Drug Administration. Our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg Epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (BTKA). We will be estimating whether Epidiolex® is associated with minimal opioid use and adequate analgesia. We will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.

Timeline

Start
2022-11-02
Primary completion
2024-10-11
Completion
2025-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 400 mg Oral
Subject Cannabidiol Other / unclassified 800 mg Oral