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NCT04749628 · ClinicalTrials.gov registry record · Phase 4
Cannabidiol for Bilateral Total Knee Arthroplasty
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT04749628: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT04749628 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04749628, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG cannabidiol
- OTHER Ora-sweet SF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2025-01-08 |
| Phase | Phase 4 |
What the finished NCT04749628 record still lists
NCT04749628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which cannabidiol is the first listed.
NCT04749628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04749628 about?
NCT04749628 is a clinical study titled "Cannabidiol for Bilateral Total Knee Arthroplasty". 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 pop...
What is the current status of trial NCT04749628?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2022-11-02. Estimated completion is 2025-01-08.
What interventions are being tested in trial NCT04749628?
The interventions under investigation include: cannabidiol (DRUG), Ora-sweet SF (OTHER).
Who is sponsoring clinical trial NCT04749628?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04749628's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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