Aprepitant to Improve Same Day Discharge for TKA

NCT07639723 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB2026-0126
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

• difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care

  difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care. Subjects will be randomized to either the aprepitant group (administration of aprepitant, ondansetron, and dexamethasone) or control (ondansetron, dexamethasone, and placebo). PACU and ASU staff will collect real time data with regard to the primary and secondary reason for any hospital admission (PONV, Pain control, Rapid response team called, Vital sign abnormalities, Change in mental status, Other). Same day discharge will be defined by patients who are discharged from the hospital before 12 A.M day of surgery. We will use the validated simplified PONV Impact Scale that uses patient assessment of nausea and vomiting to identify clinically important PONV upon PACU and ASU discharge (a PONV impact scale score of greater than or equal to 5 defines clinically important PONV).

  patients will be followed from arrival for surgery to 7 days post operatively

Secondary Outcomes (12)

• Rescue antiemetics

  From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first

• Incidence of vomiting

  Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU

• patients with no PONV

  arrival at hospital to post op day 7

• Compare the incidence of PONV in PACU and ASU

  Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU

• Clinically important PONV

  Upon post-anesthesia care unit (PACU) arrival (within ~2-3 hours after procedure), upon PACU discharge (~4-5 hours after procedure/medically cleared to leave PACU), admission to ASU directly after medically cleared from PACU to discharge from ASU

Study Arms (2)

aprepitant

EXPERIMENTAL

Single intravenous (IV) bolus of 32mg aprepitant preoperatively , in addition to the standard antiemetic protocol (4 mg IV dexamethasone after induction of MAC sedation anesthesia and 4 mg IV ondansetron at surgical closure)

Drug: Aprepitant Injection; Drug: Ondansetron (Zofran); Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Single intravenous (IV) bolus of 32mg of placebo preoperatively, in addition to the standard antiemetic protocol (4 mg IV dexamethasone after induction of MAC sedation anesthesia and 4 mg IV ondansetron at surgical closure)

Drug: Ondansetron (Zofran); Drug: Dexamethasone; Other: Placebo

Interventions

Aprepitant Injection DRUG

32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy

aprepitant

Dexamethasone DRUG

4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy

Placebo; aprepitant

Placebo OTHER

Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Placebo

Ondansetron (Zofran) DRUG

4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy

Placebo; aprepitant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving primary, unilateral elective TKA with or without abductor canal block
• Asa I-III
• Age 18-90
• Ability to receive ondansetron and dexamethasone
• Ability to consent and complete surveys
• English or Spanish speaking
• Receiving regional anesthesia (epidural or spinal) for surgery

You may not qualify if:

• Allergy to any of the anti-emetics being administered
• Current treatment of pimozide
• Emergent surgery
• Revision/ multiple revisions of TKA
• Clinical suspicion of possible bowel obstruction
• Need for general anesthesia
• Pregnant/breast feeding
• AST\> 2.5 x the upper limit of normal or ALT\> 2.5 x upper limit of normal, bilirubin\> 1.5x upper limit of normal
• Need for opioid or benzodiazepine antagonists
• Not planned for same day discharge
• Enrollment in a different drug trial for TKA
• Unable to consent in English or Spanish

Sponsors & Collaborators

• Endeavor Health: lead
• Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.): collaborator

Study Sites (1)

Endeavor Health Skokie Hospital

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Steven Greenberg, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Brickner

CONTACT

847-570-1197; jessica.brickner@endeavorhealth.org

Nia Moragne

CONTACT

084-570-1197; nia.moragne@endeavorhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffery S. Vender, MD, Chair of Anesthesiology Research and Education Endeavor Health Clinical Professor, Pritzker School of Medicine The University of Chicago

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)