Suzetrigine Added to Multimodal Analgesia for Women Undergoing Minimally Invasive Hysterectomy

This will be a matched cohort study with a prospective and a retrospective component. Women undergoing laparoscopic/robotic hysterectomy with our ERAS protocol will be approached to participate in the prospective open label component of the study. In the preoperative holding area, patients will be asked about their preoperative anxiety and expectations for postoperative pain. Preoperative patient-reported anxiety will be assessed by asking the question: "On a scale from 1 to 100, how anxious are you regarding your upcoming surgery?" Postoperative anticipated opioid need will be measured by asking, "Do you anticipate requiring below average, average, or above average amount of pain medication following surgery?". Preoperatively, patients will receive the first dose of suzetrigine (100 mg) approximately 1 hour prior to surgery. Midazolam can be used for anxiolysis as needed. Intraoperatively, patients will receive the usual intraoperative ERAS analgesic regimen used at Duke university typically incorporating intraoperative opioids (typically fentanyl and hydromorphone), intraoperative IV acetaminophen 1000 mg and IV ketorolac 15 mg. In PACU, IV fentanyl will be allowed for analgesia as per standard practice. Postoperative multimodal analgesia will incorporate scheduled acetaminophen, ibuprofen and suzetrigine (50 mg q12h, oral) around the clock. Oral oxycodone will be used for rescue as required. Patients will be encouraged to wait at least 60 minutes after taking a dose of acetaminophen and ibuprofen before use of the opioid rescue. Patients will be contacted daily to collect data about verbal rating pain scores (0= no pain, 10= worst possible pain), opioid consumption and any adverse events. In addition, on day 7, additional information will be collected about patient global assessment of pain control (poor, fair, good, very good, excellent).

Cases will be matched in a 1:2 ratio by age, race, insurance status, duration of surgery, preoperative anxiety and anticipated need for analgesia with historical controls who received postoperative analgesia using our current multimodal analgesic regimen. The historical controls will be identified from a database of patients who underwent minimally invasive hysterectomy with documented end points that the investigators are using in this study. Those patients also have information documented that was collected prospectively about anxiety and anticipated analgesic needs, factors that have been shown to be associated with postoperative opioid consumption.

Inclusion criteria

• Patients ≥18 years presenting for a laparoscopic/robotic hysterectomy.
• ASA Classification I-III.

Exclusion criteria

• Chronic pain or chronic opioid therapy.
• Allergy or contraindication to any component of the multimodal analgesic regimen.
• Need to convert to an open procedure.
• Subjects with severe hepatic or renal impairment and those receiving CYP3A inhibitors.
• Inability to communicate pain scores or need for analgesics.
• Suspected or known addiction to or abuse of illicit drugs, prescription medicine(s) or alcohol within the past 2 years.
• Psychiatric disorders that, in the opinion of the investigator, may interfere with study assessments or compliance.
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
• Pregnancy.