Suzetrigine for Postoperative Pain After Total Ankle Replacement

Project Suzetrigine: The Efficacy and Safety of Suzetrigine (Journavx™) Following Total Ankle Arthroplasty: an Exploratory Prospective Cohort Study

This study is testing whether adding a non-opioid pain medicine called suzetrigine (Journavx) to the usual combination of pain medicines helps people recover more comfortably after ankle replacement surgery.

Adults aged 18 to 75 who are scheduled for a first-time total ankle replacement may join. Everyone who joins will receive suzetrigine in addition to their usual pain medicines. Study visits happen at the same times as normal follow-up appointments after surgery.

At these visits, participants will rate their pain, answer questionnaires about how pain affects daily life, mood, and physical activity, report how much pain medicine they have taken, report any side effects, and have their ankle motion measured.

Total ankle arthroplasty (TAA) causes substantial acute postoperative pain, typically managed with multimodal analgesia including acetaminophen, NSAIDs, and as-needed opioids. Reducing early postoperative opioid exposure is a recognized priority.

Suzetrigine is a selective NaV1.8 sodium channel inhibitor acting on peripheral pain-sensing neurons. This single-arm, open-label prospective cohort study enrolls patients undergoing primary TAA who will receive suzetrigine in addition to standard multimodal analgesia. Outcomes are compared with a historical control group of patients who underwent primary TAA at the same institution during the preceding five years and received standard multimodal analgesia alone, identified retrospectively.

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