Cannabidiol for Bilateral Total Knee Arthroplasty

NCT04749628 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-1688
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Usage in First 72 Hours Postoperatively

  Cumulative opioid usage over the first 72 hours after surgery. Measured in morphine equivalents (ME), a scale that measure opioid usage among all opioid medications

  0-72 hours postoperatively

Secondary Outcomes (19)

• Pharmacokinetics of CBD

  0, 1, 2, 3, 4, 6 hours after medication administration

• Levels of Plasma Inflammatory Marker Interleukin-6

  Preoperative, Postoperative day 1

• NRS Pain at Rest

  Preoperatively; postoperatively in the PACU, morning of postoperative day (POD) 1,2,3,4,7 and at 3 months

• NRS Pain With Movement

  Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months

• Brief Pain Inventory Short Form

  Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 months

Study Arms (3)

Ora-sweet SF

PLACEBO COMPARATOR

Other: Ora-sweet SF

400mg cannabidiol

EXPERIMENTAL

Drug: cannabidiol

800mg cannabidiol

EXPERIMENTAL

Drug: cannabidiol

Interventions

cannabidiol DRUG

Epidiolex (cannabidiol) oral solution

Also known as: Epidiolex

400mg cannabidiol; 800mg cannabidiol

Ora-sweet SF OTHER

Ora-sweet SF placebo

Ora-sweet SF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Alexandra Sideris
• Organization: Hospital for Special Surgery

siderisa@hss.edu

212.774.2602

Study Officials

• Alexandra Sideris, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: November 2, 2022
• Primary Completion: October 11, 2024
• Study Completion: January 8, 2025
• Last Updated: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)