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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well CBD oil (Cannabidiol Oil) manages pain after knee surgery compared to standard opioid medications like Percocet. The study will determine if CBD oil is as effective as opioids, which are commonly used but can have serious side effects. Participants will be divided into groups receiving different doses of CBD oil or the usual opioid treatment. This trial suits those needing knee arthroscopy for soft tissue or knee injuries and who can complete surveys and attend follow-up visits.

As an Early Phase 1 trial, this research focuses on understanding how CBD oil works in people, offering participants the opportunity to explore this potential alternative to opioids.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cannabidiol (CBD) is generally well-tolerated. Some studies have found side effects like dry mouth, diarrhea, reduced appetite, and drowsiness, but these do not affect everyone.

A review indicates that CBD is safe at lower doses, such as under 60mg per day. This trial tests higher doses to assess tolerance. CBD is already approved for certain conditions, suggesting general safety, but each use can vary.

CBD has reduced pain in some patients after surgeries, making it a promising option for managing pain without opioids. It is important to consult healthcare providers about any concerns or questions regarding new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for postoperative knee pain, which typically involves opioids like Percocet, Cannabidiol (CBD) oil offers a non-opioid alternative that may reduce the risk of dependency and side effects associated with opioids. CBD oil is derived from cannabis plants and is believed to interact with the body's endocannabinoid system, which may help in managing pain and inflammation. Researchers are excited about CBD because it could provide effective pain relief without the side effects commonly associated with traditional opioid treatments. Additionally, the use of CBD oil in this context could pave the way for more natural and holistic pain management options.

What evidence suggests that this trial's treatments could be effective for postoperative knee pain?

This trial will compare the effects of Cannabidiol (CBD) oil with standard opioid care for postoperative knee pain. Research has shown mixed results for CBD oil in pain relief. Some studies found that CBD reduced arthritis and joint pain by 44%. However, other research indicated that CBD did not significantly help with pain after knee surgery or in knee osteoarthritis. Most studies comparing CBD to a placebo showed no better pain relief with CBD. This suggests that while some individuals might experience less pain with CBD, it doesn't work the same for everyone. Participants in this trial will receive either standard opioid treatment or one of two dosages of CBD oil to evaluate its effectiveness in managing postoperative knee pain. ^{6 7 8 9 10}

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 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 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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9400326/

Cannabidiol as a treatment for arthritis and joint pain The overall cohort reported a 44% reduction in pain after CBD use (P<0.001). The osteoarthritis group had a greater percentage reduction (P=0. ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540322003837

Topical Cannabidiol (CBD) After Total Knee Arthroplasty ... One randomized controlled trial reported no reduction in postoperative pain with the use of topical CBD, although the study size was small.69 Zynrelef was ...

3. withpower.com withpower.com/trial/early-phase-1-pain-postoperative-6-2023-48275

CBD Oil for Postoperative Knee Pain (CBDS Trial) 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 ...

4. jpain.org jpain.org/article/S1526-5900(23)00582-5/fulltext

Cannabidiol (CBD) Products for Pain: Ineffective ... Fifteen of the 16 RCTs were negative: no greater pain-relieving effect for CBD than for placebo. Meta-analyses link CBD to increased rates of serious adverse ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10679851/

The use of cannabidiol (CBD) as an analgesic component 8 weeks of high-dose CBD as an add-on therapy to paracetamol do not provide an analgesic effect when compared to placebo in patients with knee osteoarthritis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol CBD reduced joint swelling, immune cell infiltration. thickening of the synovial membrane, and nociceptive sensitization/spontaneous pain in a dose-dependent ...

7. mayoclinic.org mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/is-cbd-safe-and-effective/faq-20446700

CBD: Safe and effective? CBD use also carries some risks. Though it's often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10846110/

Cannabidiol for Postoperative Pain Control After Arthroscopic ... Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR).

9. tga.gov.au tga.gov.au/sites/default/files/review-safety-low-dose-cannabidiol.pdf

Safety of low dose cannabidiol The review found that cannabidiol presents a good safety and tolerability profile at the low dose range of under 60mg/day. • The review identified that ...

10. health.harvard.edu health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496

Cannabidiol (CBD): What we know and what we don't One animal study from the European Journal of Pain suggests CBD could help lower pain and inflammation due to arthritis when applied to skin.