Cannabidiol for Knee Surgery Pain

Overseen By William Chan, MEng

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Cannabis, Opioids, SSRIs, SNRIs

Disqualifiers: Substance abuse, Psychiatric illness, Cardiovascular disorder, Hepatic insufficiency, Rheumatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the cannabis-derived medication Epidiolex® manages pain after knee surgery, potentially reducing the need for opioids. Participants will receive either a placebo or one of two doses of Epidiolex®, and researchers will study its effects on pain relief and inflammation. Ideal participants are those already scheduled for same-day double knee replacements, who haven't used cannabis recently, and who have a basic level of physical health. As a Phase 4 trial, Epidiolex® is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using cannabis, cannabinoids, hemp products, chronic opioids, Coumadin, SSRIs, SNRIs, valproate, clobazam, and steroids. If you are taking any of these, you would need to stop before participating.

What is the safety track record for cannabidiol?

Research has shown that cannabidiol (CBD) is generally safe for humans. Studies indicate that CBD is usually well-tolerated, with no major safety concerns at moderate doses. However, some side effects, such as liver damage or fertility issues, could occur, though these are rare. Small clinical trials have found CBD to be mostly safe, but more information from larger studies is still needed.

Epidiolex®, the CBD product under testing, has already received FDA approval for other uses, indicating it has passed strict safety checks. While CBD might help reduce the need for strong painkillers like opioids, its pain relief effects can vary from person to person.

Overall, there is confidence in CBD's safety, but discussing any concerns with a doctor before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for knee surgery pain, which often involve opioids or NSAIDs, cannabidiol (CBD) offers a unique approach. Researchers are excited about CBD because it leverages a different mechanism of action by interacting with the body's endocannabinoid system, potentially reducing pain and inflammation without the side effects associated with opioids. Furthermore, CBD's natural origin and lower risk of addiction make it an appealing alternative for post-surgical pain management. This trial is exploring CBD in different dosages—400mg and 800mg—to determine the most effective and safe option for patients.

What evidence suggests that cannabidiol might be an effective treatment for knee surgery pain?

Research suggests that cannabidiol (CBD) might help manage pain after surgery. In this trial, participants will receive either a 400 mg or 800 mg dose of CBD, or a placebo. Some studies have found that a 400 mg dose of CBD can reduce pain, resulting in less discomfort for patients. However, an 800 mg dose may lead to more side effects compared to lower doses or a placebo. While many patients believe CBD could be effective for pain relief, other studies have shown little to no significant improvement in pain with CBD use. Early research also suggests that CBD might help reduce inflammation, but human studies provide limited information. Overall, evidence on CBD's effectiveness for post-surgery pain is mixed, with some studies showing positive results and others showing little benefit. ^{2 5 6 7 8}

Who Is on the Research Team?

Alexandra Sideris, PhD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 scheduled for bilateral knee replacements who are generally healthy (ASA Physical Status 1 or 2). It's not for those with severe health issues, recent cannabis use, chronic opioid use, certain medication usage, or major psychiatric history.

Inclusion Criteria

I am scheduled for knee replacement surgery on both knees with approved surgeons.

I am in good or mild systemic disease state according to ASA.

Exclusion Criteria

I am taking Coumadin.

I have been diagnosed with a condition like rheumatoid arthritis or multiple sclerosis.

You have been using opioid pain medication for more than three months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 400mg or 800mg Epidiolex® or placebo during the perioperative period for bilateral total knee arthroplasty

1 week

Daily visits during hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and various outcomes such as pain, anxiety, and sleep quality

3 months

Multiple visits including postoperative days 1, 2, 3, 4, 7, and at 3 months

Long-term follow-up

Participants' range of motion and other long-term outcomes are assessed

6 weeks

Visit at 6 weeks postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• cannabidiol

Trial Overview The study tests Epidiolex®, an FDA-approved oral CBD solution. Participants will receive either a placebo, 400mg or 800mg of Epidiolex® to see if it reduces opioid need and pain after knee surgery while checking its safety and effects on body inflammation.

How Is the Trial Designed?

Group I: 800mg cannabidiol Experimental Treatment 1 Intervention

Group II: 400mg cannabidiol Experimental Treatment 1 Intervention

Group III: Ora-sweet SF Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35390457/

Topical Cannabidiol (CBD) After Total Knee Arthroplasty ... These results suggest that the local effects of topical CBD are not beneficial for providing additional pain relief after TKA.

2. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf110/8238175

Cannabis and cannabidiol for postoperative pain ... Preclinical studies have also shown enhanced bone healing and reduced proinflammatory cytokine release with CBD administration, though data in the human ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023005825

Cannabidiol (CBD) Products for Pain Ten of these 11 trials showed that CBD produced little or no pain relief, with no statistical or clinically significant difference between CBD and ...

4. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A38

OP60 Effects of cannabidiol (CBD) oral solution in patients ... Patients randomized to the 400 mg CBD also had lower pain scores, while patients in the 800 mg CBD had more side-effects compared to placebo and 400 mg CBD.

5. hub.jbjs.org hub.jbjs.org/reader.php?rsuite_id=e94f6893-3f4d-4b29-bad6-cc3bcee0d470

Cannabidiol Perceptions and Use in the Orthopaedic ... Over 80% of the surveyed patients agreed that CBD might be effective for pain management (p < 0.05). ... Data are presented as means ± 95% CI for ...

6. 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.

7. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(22)00383-7/abstract

Topical Cannabidiol (CBD) After Total Knee ... Topical Cannabidiol (CBD) After Total Knee Arthroplasty Does Not Decrease Pain or Opioid Use: A Prospective Randomized Double-Blinded Placebo- ...

8. arthritis.org arthritis.org/health-wellness/healthy-living/managing-pain/pain-relief-solutions/cbd-for-arthritis-pain

CBD for Arthritis Pain: What You Should Know So far, no serious safety concerns have been associated with moderate doses, but CBD may cause liver damage or fertility issues. It also has the potential to ...