Cannabidiol for Bilateral Total Knee Arthroplasty

NCT ID: NCT04749628

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2025-01-08

Brief 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.

Conditions

Pain, Postoperative; Opioid Use; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ora-sweet SF

Group Type: PLACEBO_COMPARATOR

Ora-sweet SF

Intervention Type: OTHER

Ora-sweet SF placebo

400mg cannabidiol

Group Type: EXPERIMENTAL

cannabidiol

Intervention Type: DRUG

Epidiolex (cannabidiol) oral solution

800mg cannabidiol

Group Type: EXPERIMENTAL

cannabidiol

Intervention Type: DRUG

Epidiolex (cannabidiol) oral solution

Interventions

cannabidiol

Epidiolex (cannabidiol) oral solution

Intervention Type: DRUG

Ora-sweet SF

Ora-sweet SF placebo

Intervention Type: OTHER

Other Intervention Names

Epidiolex

Eligibility Criteria

Inclusion Criteria

• Age 18 to 75
• Scheduled for same-day bilateral total knee replacements with participating surgeons
• American Society of Anesthesiologists (ASA) Physical Status 1 or 2

Exclusion Criteria

• ASA 3 and higher
• Weight < 40kg
• Planned use of general anesthesia
• Contraindication to major components of study protocol
• Cannabis or cannabinoid use within the past 3 months (recreational and/or medical)
• Use or ingestion of hemp seeds or hemp oil in any form within the past 30 days
• Chronic opioid use (>3 months)
• Coumadin use
• Current use of SSRI or SNRIs
• History of substance abuse or dependence
• Active or history of major psychiatric illness
• Severe cardiovascular disorder
• Severe hepatic or renal insufficiency (transaminase levels above ULN)
• History of epilepsy
• Diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, etc.)
• Use of valproate or clobazam
• Known or suspected hypersensitivity, allergy, or contraindication to cannabinoids or any of the excipients in the study medications (i.e. sesame oil, sucralose, strawberry flavor)
• Active use of steroids - oral steroids upon admission
• Stress dose steroids
• Non-English speakers
• Planned discharge to home without caregiver(s)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Sideris, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2019-1688

Identifier Type: -

Identifier Source: org_study_id