PONVPhase 4NCT07639723
Aprepitant to Improve Same Day Discharge for TKA
A Phase 4 study testing Aprepitant Injection, Ondansetron (Zofran) and Dexamethasone in people with PONV, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PONV
- What is being tested?
- Aprepitant Injection, Ondansetron (Zofran) and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Endeavor Health Skokie Hospital
Skokie, Illinois, 60076
Jessica Brickner, 847-570-1197, jessica.brickner@endeavorhealth.org
Nia Moragne, 847-570-1197, nia.moragne@endeavorhealth.org
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- PONV
- Being tested
- Aprepitant Injection, Ondansetron (Zofran), Dexamethasone, Placebo
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant InjectionDrug
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
DexamethasoneDrug
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
PlaceboOther
Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Ondansetron (Zofran); Drug: Dexamethasone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: patients will be followed from arrival for surgery to 7 days post operatively
Secondary outcomes (12)
Rescue antiemetics
Compare rescue antiemetics doses and counts given during the hospital stay in each group.
Measured: From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first
Incidence of vomiting
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)
Measured: 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
Compare the number of patients in each group who experience no PONV.
Measured: arrival at hospital to post op day 7
Compare the incidence of PONV in PACU and 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)
Measured: 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
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
Measured: 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
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.
Measured: Discharge of hospital to 7 days post operatively
Postoperative Delirium Measured by 4AT Assessment
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
Measured: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).
Compare APFEL Score
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
Measured: Preoperatively in Holding area
Compare length of stays between groups
Compare PACU length of stay (hours) and hospital length of stay (hours) between groups.
Measured: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
opioid consumption
Compare opioid consumption in morphine milligram equivalents (MMEs) between groups intraoperatively, in PACU, and during the total hospital period.
Measured: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction
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).
Measured: post operative day 1 and 5
Adverse Events
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
Measured: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.)
- Responsible party
- Principal investigator, Steven Greenberg, Endeavor Health
- Investigators
- Steven Greenberg, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639723
- Sponsor's protocol ID
- IRB2026-0126
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Aprepitant to Improve Same-Day Discharge After Total Knee Arthroplasty: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07639723
- Acronym / sponsor ID
- IRB2026-0126
- Conditions
- PONV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aprepitant | Experimental | Drug: Aprepitant Injection, Drug: Ondansetron (Zofran), Drug: DexamethasoneSingle 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) |
| Placebo | Placebo comparator | Drug: Ondansetron (Zofran), Drug: Dexamethasone, Other: PlaceboSingle 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant Injection32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy | Drug | aprepitant |
| Ondansetron (Zofran)4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy | Drug | Placebo, aprepitant |
| Dexamethasone4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy | Drug | Placebo, aprepitant |
| PlaceboPatients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy | Other | Placebo |
Primary outcome
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).
12 secondary outcomes
Rescue antiemetics
Time frame: From date of admission to perioperative procedural area until hospital discharge or up to 30 days whichever is first
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
patients with no PONV
Time frame: arrival at hospital to post op day 7
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
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
Readmission rates
Time frame: Discharge of hospital to 7 days post operatively
Postoperative Delirium Measured by 4AT Assessment
Time frame: Preoperative baseline and upon PACU discharge (~4 hours after procedure/medically cleared to leave PACU).
Compare APFEL Score
Time frame: Preoperatively in Holding area
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)
opioid consumption
Time frame: From date of procedure through hospital discharge (up to 30 days after procedure date, whichever comes first)
Patient Satisfaction
Time frame: post operative day 1 and 5
Adverse Events
Time frame: These events will be assessed after immediate administration in the preoperative holding area and within 4 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and to protect participant privacy.
Related trials for PONV
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Greenberg, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant Injection, Ondansetron (Zofran) and Dexamethasone in people with PONV, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Brickner (847-570-1197, jessica.brickner@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.