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Cannabinoid

Cannabidiol for Knee Surgery Pain

Phase 4
Recruiting
Led By Alexandra Sideris, PhD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for same-day bilateral total knee replacements with participating surgeons
American Society of Anesthesiologists (ASA) Physical Status 1 or 2
Must not have
Coumadin use
Active or history of major psychiatric illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at hospital discharge to pod7 and at 3 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study the effects of Epidiolex, a cannabidiol medication, on patients undergoing a common knee surgery. The goal is to see if Epidiolex can help reduce pain and the need for opioids.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects aren't detailed here, CBD can typically cause drowsiness, changes in appetite/weight, diarrhea, fatigue. The trial will monitor tolerability and any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for knee replacement surgery on both knees with approved surgeons.
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I am in good or mild systemic disease state according to ASA.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking Coumadin.
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I have a history of or currently have a major psychiatric illness.
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I am currently taking medication for depression or anxiety.
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I have been diagnosed with a condition like rheumatoid arthritis or multiple sclerosis.
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I do not speak English.
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I am currently taking valproate or clobazam.
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I am not allergic to cannabinoids, sesame oil, sucralose, or strawberry flavor.
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I am allergic or cannot tolerate key parts of the study treatment.
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I weigh less than 40kg.
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I will be undergoing surgery with general anesthesia.
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I am currently taking oral steroids.
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I am taking high doses of steroids for stress.
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I have a severe heart condition.
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My liver or kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge to pod7 and at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge to pod7 and at 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative Opioid Usage in First 72 hours Postoperatively
Secondary study objectives
Anxiety levels
Blinding Assessment
Brief Pain Inventory Short Form
+13 more

Side effects data

From 2017 Phase 2 trial • 13 Patients • NCT02818777
85%
Diarrhea
69%
Somnolence
62%
Fatigue
38%
Elevated liver function tests
31%
Weight gain
23%
Abdominal pain
23%
Dizziness
15%
anorexia
15%
weight loss
15%
nausea
15%
headache
15%
increased appetite
8%
fever
8%
weakness
8%
vomiting
8%
flatulence
8%
gastroesophageal reflux
8%
allergic reaction
8%
spasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cannabidiol

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 800mg cannabidiolExperimental Treatment1 Intervention
Group II: 400mg cannabidiolExperimental Treatment1 Intervention
Group III: Ora-sweet SFPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cannabidiol
2010
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,299 Total Patients Enrolled
2 Trials studying Infections
785 Patients Enrolled for Infections
Alexandra Sideris, PhDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04749628 — Phase 4
Infections Research Study Groups: 400mg cannabidiol, Ora-sweet SF, 800mg cannabidiol
Infections Clinical Trial 2023: cannabidiol Highlights & Side Effects. Trial Name: NCT04749628 — Phase 4
cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04749628 — Phase 4
~8 spots leftby Jul 2025
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