CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
Dronabinol 5mg Cap +1 moredrug
Likely dose
Dronabinol 5mg Capfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04734080
NCT04734080Phase 4Completed

Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty

Hospital for Special Surgery, New York·interventional·Posted Feb 2, 2021·Updated Mar 27, 2026

In Brief

A Phase 4 clinical trial evaluating Dronabinol 5mg Cap and Placebo oral tablet for Total Knee Arthroplasty and Opioid Use. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedFeb 2, 2021
Enrollment StartMar 9, 2021
Primary CompletionOct 6, 2023
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.4 years ago

Interventions

Dronabinol 5mg Capdrug

Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.

Placebo oral tabletother

Non-active placebo