Aprepitant for Postoperative Nausea and Vomiting

JB
NM
Overseen ByNia Moragne
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to study whether adding an FDA approved medication called aprepitant (a medication given to patients like you to reduce or eliminate nausea and vomiting) to the usual treatment to prevent nausea and vomiting given to patients during knee replacement surgery helps more patients go home on the same day of surgery (before midnight) by eliminating nausea and vomiting.

Who Is on the Research Team?

SG

Steven Greenberg, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 having a planned, single knee replacement surgery with regional anesthesia. Participants must be able to take ondansetron and dexamethasone, speak English or Spanish, and be able to give consent and complete surveys.

Inclusion Criteria

I am able to give consent and complete surveys.
I am having my first knee replacement surgery on one knee.
English or Spanish speaking
See 4 more

Exclusion Criteria

I require general anesthesia for my procedure.
Enrollment in a different drug trial for TKA
I cannot give consent in English or Spanish.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive either aprepitant or placebo preoperatively, along with standard antiemetic protocol

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for nausea and vomiting, and receive rescue antiemetics as needed

7 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and adverse events

7 days

What Are the Treatments Tested in This Trial?

Interventions

  • Aprepitant

Trial Overview

The study tests if adding aprepitant (an anti-nausea drug) to the usual medications (ondansetron and dexamethasone) helps prevent nausea after knee replacement surgery so more patients can go home the same day. Some participants may receive a placebo instead of aprepitant.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: aprepitantExperimental Treatment3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials
135
Recruited
742,000+

Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.)

Collaborator