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Dronabinol for Pain Management after Total Knee Replacement

Phase 4

Waitlist Available

Led By Kethy Jules-Elysee, M.D.

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

Patients aged between 18-70 years old with osteoarthrosis scheduled for primary unilateral knee arthroplasty with a participating surgeon

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge

Awards & highlights

Study Summary

This trial will investigate whether the use of dronabinol, a cannabinoid, can reduce pain and the need for opioids following total knee arthroplasty.

Who is the study for?

This trial is for adults aged 18-70 undergoing knee replacement surgery who plan to use regional anesthesia. It's not for those with a BMI ≥40, chronic opioid users, severe systemic disease (ASA IV+), major mental health history, on certain medications like anticonvulsants or Coumadin, non-English speakers, under 18 or over 70 years old, using general anesthesia, with a history of seizures or revision surgery.Check my eligibility

What is being tested?

The study tests if Dronabinol reduces the need for opioids after knee surgery compared to a placebo. Participants are randomly assigned to receive either Dronabinol or placebo and will answer surveys about pain and nausea/vomiting. They'll also be monitored for oxygen levels and sleep quality to see if there's an impact on recovery milestones.See study design

What are the potential side effects?

Dronabinol may cause side effects such as dizziness, dry mouth, sleepiness or fatigue, mood changes, increased appetite and altered sensory perceptions. More serious but less common side effects include heart palpitations and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18-70 years old and scheduled for knee replacement due to osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post operative discharge, 48 hours post operative discharge, 3 months post operative discharge, 6 months post operative discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Consumption 24-48 hours post-operatively

Secondary outcome measures

Cognitive assessment

DN4 score

Length of stay (hours)

+11 more

Side effects data

From 2019 Phase 4 trial • 72 Patients • NCT03604341

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Gestational Age up to 10w0d - Placebo

Gestational Age up to 10w0d - Dronabinol

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DronabinolExperimental Treatment1 Intervention

57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.

Group II: PlaceboPlacebo Group1 Intervention

57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronabinol 5mg Cap

2021

Completed Phase 4

~190

0 / 1Eligibility criteria met