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Trial eligibility change
| eligibility_criteria | Inclusion Criteria: \- Adult patients aged 18-75 years Undergoing primary total ankle arthroplasty (TAA) Capable of completing questionnaires Capable of providing consent for enrollment Capable of using Suzetrigine times a day Capable of completing the follow-up visits Exclusion Criteria: \- BMI ≥ 50 kg/m² Pre-operative/current opioid consumption Prior history of ipsilateral ankle infection Severe hepatic impairment (Child-Pugh Class C) eGFR \< 30 ml/min Pregnant or lactating Heart failure or recent myocardial infarction Using strong CYP3A inhibitors (e.g., itraconazole) or strong/moderate CYP3A inducers (e.g., Rifampin) Women taking concomitant progestin-containing contraceptives other than levonorgestrel and norethindrone who are unwilling to use additional non-hormonal contraceptives (such as condoms) or alternative contraceptives during Suzetrigine treatment and for 28 days after discontinuation | → | Inclusion Criteria: * Adult patients aged 18-75 years * Undergoing primary total ankle arthroplasty (TAA) * Capable of completing study questionnaires * Capable of providing informed consent for enrollment * Capable of taking suzetrigine twice daily * Capable of completing the required follow-up visits Exclusion Criteria: * Declines to participate or discontinues participation during the study * Body mass index (BMI) ≥50 kg/m² * Preoperative or current opioid use * Prior history of ipsilateral ankle infection * Severe hepatic impairment (Child-Pugh Class C) * Estimated glomerular filtration rate (eGFR) \<30 mL/min * Pregnant or lactating * Heart failure or recent myocardial infarction * Requires non-antiplatelet anticoagulant therapy (e.g., heparin, warfarin \[Coumadin\], apixaban \[Eliquis\], or enoxaparin \[Lovenox\]) * Use of strong cytochrome P450 3A (CYP3A) inhibitors (e.g., itraconazole) or strong or moderate CYP3A inducers (e.g., rifampin) * Women taking concomitant progestin-containing contraceptives other than levonorgestrel or norethindrone who are unwilling to use an additional non-hormonal contraceptive method (e.g., condoms) or an alternative contraceptive during suzetrigine treatment and for 28 days after discontinuation |
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