Suzetrigine for Postoperative Pain After Total Ankle Replacement

NCT07795827 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2026P000137
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Osteoarthritis; Postoperative Pain; Acute Pain

Keywords

suzetrigine; total ankle arthroplasty; postoperative pain management; foot and ankle surgery

Outcome Measures

Primary Outcomes (1)

• Cumulative Postoperative Opioid Consumption Through Postoperative Day 14

  Cumulative opioid consumption will be calculated as the total amount of opioid medication used from postoperative day 0 through postoperative day 14 and converted to morphine milligram equivalents (MME). Higher MME values indicate greater opioid consumption.

  Postoperative day (POD) 0 through Postoperative Day 14

Secondary Outcomes (12)

• Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS)

  24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

• Pain Interference Assessed by PROMIS Pain Interference 6b

  24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

• Pain Intensity Assessed by PROMIS Pain Intensity 3a

  24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

• Physical Function Assessed by PROMIS Physical Function 10a

  24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

• Pain Intensity Assessed by the Visual Analog Scale

  24 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

Study Arms (1)

Group

EXPERIMENTAL

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

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

Oral suzetrigine administered postoperatively in addition to standard multimodal analgesia.

Also known as: Journavx

Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soheil Ashkani Esfahani: lead
• Vertex Pharmaceuticals Incorporated: collaborator

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mani Eftekhari, BS

CONTACT

5108506056; meftekhari@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Foot & Ankle Research and Innovation Lab (FARIL)

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share