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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.
Pain Intensity (NPRS)
Numerical Pain Rating Scale
Time frame: Baseline, 24 hours, 2 weeks, 1 month, 3 months, 6 months after surgery
Pain Intensity (VAS)
Visual Analog Scale
Time frame: Baseline, 24 hours, 2 weeks, 1 month, 3 months, 6 months after surgery
Opioid Consumption
Total opioid use
Time frame: 2 weeks, 1 month, 3 months, 6 months after surgery
PROMIS Scores
PROMIS Pain Interference, Physical Function, Depression, and Anxiety
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months after surgery
Adverse Events
Adverse Events
Time frame: 2 weeks, 1 month, 3 months, 6 months after surgery
Ankle Range of Motion
Ankle range of motion in degrees
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months after surgery
Patient Satisfaction
Likert scale
Time frame: 2 weeks, 1 month, 3 months, 6 months after surgery
Opioid Misuse Risk
Opioid Risk Tool
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months
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