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NCT Number: NCT07639723

Aprepitant to Improve Same Day Discharge for TKA

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

This is a prospective, randomized, double-blind, placebo-controlled trial involving adults undergoing primary total knee arthroplasties at Endeavor Health SKH with presumed same-day discharge (as identified by the orthopedic surgery team prior to surgery). Patients will be randomly assigned to either receive 32 mg of intravenous (IV) preoperative aprepitant, 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), or the standard protocol with placebo (saline solution in same volume at the time aprepitant is given in the preoperative holding area by nursing). Aprepitant will be administered by the preoperative nurse in the holding area to ensure blinding of the anesthesia, surgical, and postoperative teams. All patients will receive either epidural or spinal anesthesia following our standard regional anesthesia protocol, with or without an adductor canal block. Intraoperatively, all patients will receive propofol infusions titrated to a RASS of 0 to -2 per the standard of care protocol at SKH. All patients will receive postoperative rescue antiemetics as needed and within the PACU admission order set choices for PONV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Aprepitant Injection

Drug

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

ondansetron (Zofran)

Drug

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

Dexamethasone

Drug

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

Placebo

Other

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

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Rescue antiemetics

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

    Compare rescue antiemetics doses and counts given during the hospital stay in each group.

  2. Incidence of vomiting

    Time frame: 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

    Compare the incidence of vomiting between both groups in PACU and ASU (None = No PONV symptoms, Mild = Patient feels queasy but is able to take PO, will treat with alcohol pads and/or QueaseEASE, Moderate = Patient is unable to take PO and is restless, will treat with rescue antiemetics per standard PACU orderset, Severe = Actively vomiting, will treat with rescue antiemetics per standard PACU orderset)

  3. patients with no PONV

    Time frame: arrival at hospital to post op day 7

    Compare the number of patients in each group who experience no PONV.

  4. Compare the incidence of PONV in PACU and ASU

    Time frame: 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

    Compare the incidence of PONV between both groups in PACU and ASU using Endeavor Health SKH PACU PONV assessment scales, and stratify both groups by none, mild, moderate, and severe PONV (None = No PONV symptoms, Mild = Patient feels queasy but is able to take PO, will treat with alcohol pads and/or QueaseEASE, Moderate = Patient is unable to take PO and is restless, will treat with rescue antiemetics per standard PACU orderset, Severe = Actively vomiting, will treat with rescue antiemetics per standard PACU orderset)

  5. Clinically important PONV

    Time frame: 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

    Compare the incidence of clinically important PONV between both groups in PACU and ASU using the validated simplified PONV Impact Scale. a PONV impact scale score of greater than or equal to 5 defines clinically important PONV

  6. Readmission rates

    Time frame: Discharge of hospital to 7 days post operatively

    Compare readmission rates within 7 days postoperatively, stratified by admissions due to nausea/vomiting or related complications, and those for other medical or surgical reasons.

  7. Postoperative Delirium Measured by 4AT Assessment

    Time frame: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).

    Compare incidence of delirium in both groups. Delirium will be detected using the 4AT validated survey upon PACU discharge compared to a preoperative baseline assessment Preoperative baseline

  8. Compare APFEL Score

    Time frame: Preoperatively in Holding area

    Compare Apfel Scores for Postoperative Nausea and Vomiting in both groups (determined preoperatively in holding area by research team) . Apfel score is a quick, validated clinical tool used by anesthesiologists to predict a patient's risk of developing Postoperative Nausea and Vomiting (PONV).The total score (0-4) predicts the percentage risk of developing PONV

  9. Compare length of stays between groups

    Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)

    Compare PACU length of stay (hours) and hospital length of stay (hours) between groups.

  10. opioid consumption

    Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)

    Compare opioid consumption in morphine milligram equivalents (MMEs) between groups intraoperatively, in PACU, and during the total hospital period.

  11. Patient Satisfaction

    Time frame: post operative day 1 and 5

    Compare patient satisfaction scores using a Likert scale on postoperative days 1 and 5. "The anesthesia care I received during my total knee arthroplasty (TKA) procedure met my expectations" (5= strongly agree, 1=strongly disagree) and "The management of any nausea and vomiting following my total knee arthroplasty (TKA) procedure met my expectations" (5= strongly agree, 1=strongly disagree).

  12. Adverse Events

    Time frame: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively

    Compare the adverse events that could be related to aprepitant vs. placebo between groups. These events may include but are not limited to: injection site reactions, hypersensitivity reactions or skin reactions, abdominal discomfort, constipation or diarrhea, dizziness, hiccups, headache

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Brickner

CONTACT

[email protected]

847-570-1197

Nia Moragne

CONTACT

[email protected]

084-570-1197

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

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

Registry information

Official study title

Preoperative Aprepitant to Improve Same-Day Discharge After Total Knee Arthroplasty: A Randomized Double-Blind Placebo-Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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