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Background <p>Total knee arthroplasty (TKA) is commonly performed to reduce pain and improve functional limitations associated with late-stage osteoarthritis. However, 1 in 4 patients experience persistent post-surgical pain (PPSP); a complaint that is associated with higher peri-operative pain. Cannabidiol (CBD) possesses analgesic and anti-inflammatory properties that may reduce the risk of persistent pain among TKA patients. We designed a pilot trial to assess the feasibility of a definitive trial comparing CBT to placebo for reducing PPSP in patients undergoing TKA.</p> Methods <p>We propose a randomized, controlled, pilot trial in which 40 patients scheduled to undergo TKA will be randomized to receive MPL-001 (an oral CBD-dominant formulation) or placebo, in addition to standard care. The feasibility outcomes of this pilot trial are as follows: (1) our ability to recruit 40 patients in 6 months, (2) achieve ≥75% treatment adherence among patients, and (3) &lt;15% loss to follow-up. Secondary outcomes are the effects of MPL-001 relative to placebo on PPSP, opioid use, peri-operative pain interference, physical and emotional function, return to functioning, sleep, and adverse events (AEs) up to 6&#xa0;months post-surgery.</p> Discussion <p>The results of our pilot study will inform the feasibility of a definitive trial to establish the effectiveness of CBD to reduce PPSP after TKA. If no major changes to our protocol are required, we will treat this study as a vanguard trial and enroll our pilot patients into a definitive trial.</p> Trial registration <p>We prospectively registered our trial on ClinicalTrials.gov (identifier: NCT03825965) before enrolling any patients.</p>

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Cannabidiol to reduce persistent post-surgical pain following total knee arthroplasty: protocol for a multi-centre, randomized, controlled pilot trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月25日

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  • Jason W. Busse,
  • Breanne Flood,
  • Kim Madden,
  • Vahid Ashoorion,
  • Emmanuel Olaonipekun,
  • Amit Atrey,
  • Vickas Khanna,
  • Anthony Adili,
  • Adam Weerdenburg,
  • Danielle Dagher,
  • Kim Irish,
  • Amir Khoshbin,
  • Cassandra Tardif-Theriault,
  • Herman Johal,
  • Harsha Shanthanna,
  • Allan Fein,
  • Andrew Duong,
  • Lawrence Mbuagbaw,
  • Sayem Borhan,
  • Behnam Sadeghirad

摘要

Background

Total knee arthroplasty (TKA) is commonly performed to reduce pain and improve functional limitations associated with late-stage osteoarthritis. However, 1 in 4 patients experience persistent post-surgical pain (PPSP); a complaint that is associated with higher peri-operative pain. Cannabidiol (CBD) possesses analgesic and anti-inflammatory properties that may reduce the risk of persistent pain among TKA patients. We designed a pilot trial to assess the feasibility of a definitive trial comparing CBT to placebo for reducing PPSP in patients undergoing TKA.

Methods

We propose a randomized, controlled, pilot trial in which 40 patients scheduled to undergo TKA will be randomized to receive MPL-001 (an oral CBD-dominant formulation) or placebo, in addition to standard care. The feasibility outcomes of this pilot trial are as follows: (1) our ability to recruit 40 patients in 6 months, (2) achieve ≥75% treatment adherence among patients, and (3) <15% loss to follow-up. Secondary outcomes are the effects of MPL-001 relative to placebo on PPSP, opioid use, peri-operative pain interference, physical and emotional function, return to functioning, sleep, and adverse events (AEs) up to 6 months post-surgery.

Discussion

The results of our pilot study will inform the feasibility of a definitive trial to establish the effectiveness of CBD to reduce PPSP after TKA. If no major changes to our protocol are required, we will treat this study as a vanguard trial and enroll our pilot patients into a definitive trial.

Trial registration

We prospectively registered our trial on ClinicalTrials.gov (identifier: NCT03825965) before enrolling any patients.