This study will assess the analgesic efficacy of suzetrigine as part of a multimodal analgesic regimen in women undergoing laparoscopic or robotic hysterectomy. Outcomes will be compared with matched historical controls receiving the current ERAS regimen without suzetrigine.
Patients ≥18 years presenting for a laparoscopic/robotic hysterectomy.
ASA Classification I-III.
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.
Single group
Suzetrigine
DrugSuzetrigine is an oral non-opioid pain medication used to treat moderate-to-severe acute pain in adults.
Postoperative opioid use after Post-Anesthesia Care Unit (PACU) discharge following surgery
Number of participants needing any opioids
Total post-surgical opioid consumption after PACU discharge following surgery
Total opioid consumption in mg
Average pain score in the first week following PACU discharge after surgery
Average verbal rating pain score
Pain score on day 7
Verbal rating pain score (0=no pain, 10= worst possible pain)
Duration of PACU stay
Minutes of stay in PACU
Opioid related side effects in the suzetrigine group
Number of participants with nausea, vomiting, itching, constipation and ileus
Proportion of participants reporting good, very good, or excellent on a Patient Global Assessment (PGA) for pain control at 7 days after surgery.
Number of patients reporting good, very good, or excellent on a Patient Global Assessment (PGA) for pain control at 7 days after surgery (scale includes the following responses: poor, fair, good, very good, excellent).
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Duke University
Lead sponsor
Vertex Pharmaceuticals Incorporated
Collaborator
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