Suzetrigine for Postoperative Pain After Total Ankle Replacement

Sponsor
Soheil Ashkani Esfahani
Study ID
NCT07795827
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Pain
  • Ankle Osteoarthritis
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group
    Participants undergoing primary total ankle arthroplasty receive oral suzetrigine in addition to the institution's standard multimodal analgesic regimen.

Primary Outcome Measure

Pain Intensity (NPRS) [ Time Frame: Baseline, 24 hours, 2 weeks, 1 month, 3 months, 6 months after surgery ]

Central Contacts

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