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NCT07856654
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Conditions: Pelvic Organ Prolapse (POP), Postoperative Pain, Urogynecology
Sex: Female
Ages: 40 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 48
Sponsor: Aditi Talkad
Location: University of Texas at Austin Dell Medical School, Department of Women's Health Austin Texas
Summary
The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse.
Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome.
The main questions it aims to answer are:
* Does suzetrigine reduce postoperative pain scores compared to placebo?
* Does suzetrigine reduce the need for opioid rescue medication after surgery?
Researchers will compare participants receiving suzetrigine to participants receiving placebo, both on top of standard postoperative pain management, to see if suzetrigine lowers pain scores and opioid consumption after apical suspension surgery.
Eligibility Criteria
Inclusion Criteria:
* Women ≥ 40 years and ≤ 80
* BMI \>=18.0 and \3 times the upper limit of normal or Child-Pugh class B or C.
* Diagnosis of chronic pain syndrome or fibromyalgia
* Inability to provide written informed consent
* History of significant respiratory, cardiovascular, metabolic, neurologic, or psychiatric disease as deemed clinically significant by study team
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years or QT prolongation (QTcF \>450 ms) or pacemaker/ICD
* Severe kidney disease define as Estimated glomerular filtration rate (eGFR) of ≤ 30ml/min
* Inability to receive or respond to text messages via mobile phone
* Receives transversus abdominis plane (TAP) block
* Allergy to any of the study medications
* Use of moderate or strong CYP3A inducers or inhibitors, including prescription medications, over-the-counter medications, and herbal supplements known to significantly affect CYP3A metabolism (e.g., ketoconazole, clarithromycin, rifampin, carbamazepine, phenytoin, ritonavir, and St. John's Wort).
* Pregnant or breastfeeding or planning to become pregnant within 30 days following last dose of study drug
Source: ClinicalTrials.gov (NCT07856654). StuddyBuddy aggregates publicly available trial information.