PONV
Conditions
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.
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.
Interventions
32mg aprepitant will be administered intravenously preoperatively during single sided total knee arthroscopy
4 mg IV ondansetron will be given at surgical closure during total knee arthroscopy
DRUGDexamethasone
4 mg IV dexamethasone will be given after induction of MAC sedation anesthesia during total knee arthroscopy
OTHERPlacebo
Patients will receive 32 mg of intravenous (IV) placebo preoperatively for a total knee arthroscopy
Sponsors
Endeavor Health
Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in the incidence of same-day discharges between two randomized groups of anti-emetic regimens for anesthesia care | 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
| Measure | Time frame | Description |
|---|---|---|
| Rescue antiemetics | 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. |
| 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 | 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) |
| patients with no PONV | arrival at hospital to post op day 7 | Compare the number of patients in each group who experience no PONV. |
| 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 | 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) |
| 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 | 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 |
| Readmission rates | 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. |
| Postoperative Delirium Measured by 4AT Assessment | 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 |
| Compare APFEL Score | 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 |
| Compare length of stays between groups | 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. |
| opioid consumption | 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. |
| Patient Satisfaction | 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). |
| Adverse Events | 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 |
Countries
United States
Contacts
CONTACTJessica Brickner
CONTACTNia Moragne
PRINCIPAL_INVESTIGATORSteven Greenberg, MD
Endeavor Health
Outcome results
None listed