Acute Pain, Ankle Osteoarthritis, Postoperative Pain
Conditions
Keywords
suzetrigine, total ankle arthroplasty, postoperative pain management, foot and ankle surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGSuzetrigine
Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.
Sponsors
Soheil Ashkani Esfahani
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (NPRS) | Baseline, 24 hours, 2 weeks, 1 month, 3 months, 6 months after surgery | Numerical Pain Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (VAS) | Baseline, 24 hours, 2 weeks, 1 month, 3 months, 6 months after surgery | Visual Analog Scale |
| Opioid Consumption | 2 weeks, 1 month, 3 months, 6 months after surgery | Total opioid use |
| PROMIS Scores | Baseline, 2 weeks, 1 month, 3 months, 6 months after surgery | PROMIS Pain Interference, Physical Function, Depression, and Anxiety |
| Adverse Events | 2 weeks, 1 month, 3 months, 6 months after surgery | Adverse Events |
| Ankle Range of Motion | Baseline, 2 weeks, 1 month, 3 months, 6 months after surgery | Ankle range of motion in degrees |
| Patient Satisfaction | 2 weeks, 1 month, 3 months, 6 months after surgery | Likert scale |
| Opioid Misuse Risk | Baseline, 2 weeks, 1 month, 3 months, 6 months | Opioid Risk Tool |
Contacts
CONTACTMani Eftekhari, BS
Outcome results
None listed