CBD Oil for Postoperative Knee Pain

(CBDS Trial)

Overseen By Deborah Warren, RN

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Knee dislocation, fracture, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does CBD oil differ from other treatments for postoperative knee pain?

CBD oil is unique because it is a non-psychoactive compound derived from cannabis that may offer pain relief without the intoxicating effects associated with medical marijuana. Unlike traditional pain medications, such as opioids, CBD oil is being explored for its potential to manage pain with fewer side effects and a lower risk of addiction. ^{1 2 3 4 5}

What data supports the effectiveness of the drug CBD Oil for postoperative knee pain?

The research does not provide direct evidence supporting the effectiveness of CBD Oil for postoperative knee pain. Studies have shown no significant difference in pain relief between CBD users and non-users in similar conditions, and further research is needed to determine its safety and effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a knee arthroscopy due to soft tissue injury or other acute or chronic knee issues. Participants must be able to fill out surveys and come back for follow-ups. It's not for those under 18, with past major knee injuries, surgeries, other limb problems, or if pregnant.

Inclusion Criteria

Able to complete surveys and follow-up visits

I need a knee surgery for a tissue injury.

Exclusion Criteria

I have had a knee injury, surgery, or other leg issues before.

I am under 18 years old.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants in the CBD groups receive either 100 mg or 200 mg of CBD daily for 30 days prior to surgery

4 weeks

1 visit (in-person) for pre-operative assessment

Post-operative Treatment

Participants receive either standard opioid care or continue CBD treatment for 30 days post-operatively

4 weeks

Weekly visits (in-person) for monitoring and CRF packet collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sleep quality and pain control

2 weeks

1 visit (in-person) at the end of follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol Oil

Trial Overview The study is testing the effectiveness of CBD oil in managing pain after knee surgery compared to traditional opioid medications. Patients are randomly assigned to receive either CBD oil or opioids and their pain levels are monitored.

How Is the Trial Designed?

Group I: Cannabidiol Oil 200 mg/day Experimental Treatment 1 Intervention

CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.

Group II: Cannabidiol Oil 100 mg/day Experimental Treatment 1 Intervention

CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively

Group III: Standard of Care Active Control 1 Intervention

Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

Published Research Related to This Trial

In a study of 109 patients who underwent total hip or knee replacement surgeries, 22% reported using cannabidiol (CBD) during their treatment period.

Despite the prevalence of CBD use, there was no significant difference in pain satisfaction between those who used CBD and those who did not, indicating a need for further research on the safety and efficacy of CBD in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of self-directed perioperative cannabidiol use in patients undergoing total hip or knee arthroplasty. Yu, JS., Premkumar, A., Liu, S., et al.[2021]

In a study of 195 patients undergoing total hip and knee arthroplasty, 16.4% reported using CBD/THC products during the perioperative period, with higher usage in knee arthroplasty patients (22.6%) compared to hip arthroplasty patients (11.7%).

Despite the use of CBD/THC products, there was no significant difference in opioid consumption, pain scores, or length of hospital stay between users and non-users, suggesting that these products may not significantly impact post-operative opioid requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Tetrahydrocannabinol and Cannabidiol Products in the Perioperative Period Around Primary Unilateral Total Hip and Knee Arthroplasty. Runner, RP., Luu, AN., Nassif, NA., et al.[2021]

In a study involving 20 healthy volunteers, an 800-mg oral dose of cannabidiol (CBD) did not significantly reduce pain intensity or affect hyperalgesia and allodynia compared to a placebo, suggesting limited efficacy in acute pain management.

The study highlights the need for further research on different dosages and administration methods for CBD, as well as its potential role in combination with other treatments, before concluding its effectiveness for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). Schneider, T., Zurbriggen, L., Dieterle, M., et al.[2023]

In a randomized, double-blind, placebo-controlled trial involving 136 patients with hand osteoarthritis or psoriatic arthritis, cannabidiol (CBD) did not show a significant reduction in pain intensity compared to placebo after 12 weeks of treatment.

The study found no meaningful effects of CBD on secondary outcomes such as sleep quality, anxiety, or depression, indicating that CBD may not be an effective add-on therapy for pain management in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. Vela, J., Dreyer, L., Petersen, KK., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Rates of self-directed perioperative cannabidiol use in patients undergoing total hip or knee arthroplasty. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Tetrahydrocannabinol and Cannabidiol Products in the Perioperative Period Around Primary Unilateral Total Hip and Knee Arthroplasty. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cannabinoid Use in Musculoskeletal Illness: a Review of the Current Evidence. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pain response to cannabidiol in induced acute nociceptive pain, allodynia, and hyperalgesia by using a model mimicking acute pain in healthy adults in a randomized trial (CANAB I). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol treatment in hand osteoarthritis and psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabidiol Content and In Vitro Biological Activities of Commercial Cannabidiol Oils and Hemp Seed Oils. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Clinicians' Guide to Cannabidiol and Hemp Oils. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of a cannabidiol and cannabidiolic acid rich hemp extract for pain in dogs following a tibial plateau leveling osteotomy. [2023]