Effects of cannabidiol (CBD) oral solution in patients undergoing bilateral total knee arthroplasty: a randomized, controlled, parallel, triple blind, pilot study
William Chan1, Jiabin Liu1,2, Lila Baaklini1,2, Meghan Kirksey1,2, Alex Illescas3, Seth Waldman2,3, Kethy Jules-Elysee2,3 and Alexandra Sideris1,2
| Pain Prevention Research Center (PPRC), Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, New York, USA Department of Anesthesiology, Weill Cornell Medicine, New York, USA Department of Anesthesiology, Critical Care and Pain Management, Hospital for Special Surgery, New York, USA |
Affiliationer
Background and Aims Cannabidiol (CBD) is a non-intoxicating phytocannabinoid with limited clinical evidence of its pain relieving and opioid sparing properties. In the US, an oral cannabidiol solution, Epidiolex®, is approved by the FDA for the treatment of intractable seizures. We conducted an off-label pilot study of Epidiolex® in patients undergoing bilateral total knee arthroplasty (BTKA) to assess effects on opioid requirements, pain, inflammation, tolerability, sleep, mood, and pharmacokinetics.
Methods After IRB-approval and trial registration (NCT04749628), 36 patients undergoing BTKA were randomized to receive four perioperative doses of placebo (Ora-Sweet SF) (n=12), 400 mg (n=12) or 800 mg (n=12) CBD oral solution (Epidiolex®) (figure 1) with standardized anesthesia and analgesia regimen including regional techniques. Descriptive statistics were used to summarize patient and case characteristics and outcomes; pairwise t-tests were used to compare cumulative first 72-hour opioid consumption (primary outcome) between the three groups.
Results Patient and case characteristics are summarized in table 1. Compared to placebo, patients who received 400 mg CBD had 30% lower cumulative 72-hour opioid requirements (mean: 209 MMEs versus 144 MMEs; p=0.04), with no difference between placebo and 800 mg CBD (p=0.9) or between 400 mg and 800 mg CBD (p=0.09). Patients randomized to the 400 mg CBD also had lower pain scores, while patients in the 800 mg CBD had more side-effects compared to placebo and 400 mg CBD.
Conclusions Our pilot findings suggest promising efficacy for pain relief and opioid reduction with 400 mg CBD. Adequately powered randomized controlled trials are needed and will help elucidate potential biphasic effects.
