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NCT04734080 · ClinicalTrials.gov registry record · Phase 4
Dronabinol in Total Knee Arthroplasty (TKA)
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
NCT04734080: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT04734080 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 114 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04734080, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
Study Summary
The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are: 1. Does perioperative dronabinol use (starting in the immediate preoperative period (enrollment before 1 PM), with BID dosing concluding the evening of POD2) affect postoperative opioid consumption 24-48 hours following total knee arthroplasty? 2. Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation? 3. Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control? 4. Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients? 5. Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use? Participants will: * Be randomized to take the dronabinol or placebo medication in 5 dosage * Answer survey questions in regard to pain, postop nausea/vomiting, cognitive/adverse event, and outcome quality and support of decision making. * Be connected to a Masimo to record oxygen saturation and an Actigraph to record sleep quality. Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affects postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.
Primary Outcome
The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time.
Interventions
- DRUG Dronabinol 5mg Cap
- OTHER Placebo oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 4 |
What the finished NCT04734080 record still lists
NCT04734080 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Dronabinol 5mg Cap is the first listed.
NCT04734080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04734080 about?
NCT04734080 is a clinical study titled "Dronabinol in Total Knee Arthroplasty (TKA)". The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are: 1. Does perioperative dronabinol use (starting in t...
What is the current status of trial NCT04734080?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2021-03-09. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT04734080?
The interventions under investigation include: Dronabinol 5mg Cap (DRUG), Placebo oral tablet (OTHER).
Who is sponsoring clinical trial NCT04734080?
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 NCT04734080's enrollment target sits among peer trials
114 720th of 2000 higher than 1,278 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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