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Aprepitant to Improve Same Day Discharge for TKA

6. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

350

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Medicin: Aprepitant Injection
32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
Medicin: Ondansetron (Zofran)
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
Medicin: Dexamethasone
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
Placebo komparator: 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)
Medicin: Ondansetron (Zofran)
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
Medicin: Dexamethasone
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
Andet: Placebo
Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rescue antiemetics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Endeavor Health

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Steven Greenberg, MD, Endeavor Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB2026-0126

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med PONV

Kliniske forsøg med Aprepitant Injection

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