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Aprepitant to Improve Same Day Discharge for TKA

6 juni 2026 bijgewerkt door: Steven Greenberg, Endeavor Health

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

350

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: aprepitant
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)
Geneesmiddel: Aprepitant Injection
32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
Geneesmiddel: Ondansetron (Zofran)
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
Geneesmiddel: Dexamethasone
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
Placebo-vergelijker: Placebo
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)
Geneesmiddel: Ondansetron (Zofran)
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
Geneesmiddel: Dexamethasone
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
Ander: Placebo
Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care
Tijdsspanne: 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).
patients will be followed from arrival for surgery to 7 days post operatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rescue antiemetics
Tijdsspanne: 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.
From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first
Incidence of vomiting
Tijdsspanne: 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)
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
Tijdsspanne: arrival at hospital to post op day 7
Compare the number of patients in each group who experience no PONV.
arrival at hospital to post op day 7
Compare the incidence of PONV in PACU and ASU
Tijdsspanne: 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)
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
Tijdsspanne: 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
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
Readmission rates
Tijdsspanne: 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.
Discharge of hospital to 7 days post operatively
Postoperative Delirium Measured by 4AT Assessment
Tijdsspanne: 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
Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).
Compare APFEL Score
Tijdsspanne: 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
Preoperatively in Holding area
Compare length of stays between groups
Tijdsspanne: 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.
From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
opioid consumption
Tijdsspanne: 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.
From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction
Tijdsspanne: 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).
post operative day 1 and 5
Adverse Events
Tijdsspanne: 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
These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Endeavor Health

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Steven Greenberg, MD, Endeavor Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

6 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB2026-0126

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared due to institutional policies and to protect participant privacy.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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