Menu
Enrolling by invitation NCT07723352

Journavx to Treat Pain After Thumb Basal Joint Arthroplasty

Observational Thumb Basal Joint Osteoarthritis Postoperative Pain Joint Replacement Surgery Joint Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: suzetrigine 100mg, Acetaminophen.
Who it may be relevant to
Registry conditions: Thumb Basal Joint Osteoarthritis, Postoperative Pain, Joint Replacement Surgery, Joint Replacement. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Single-Arm Open-Label Trial Evaluating the Efficacy of Suzetrigine (Journavx) in Multimodal Postoperative Pain Management Following Thumb Basal Joint Arthroplasty

Overview

The purpose of this study is to find out how well suzetrigine, a newly FDA-approved non-opioid pain medication, works to relieve pain after thumb basal joint replacement surgery. The researchers believe that suzetrigine may provide effective pain relief during recovery without the use of opioid medications.

Interventions

  • Drug suzetrigine 100mg
    Participants will receive the recommended dosing for suzetrigine, which consists of a 100 mg oral loading dose taken in the recovery room prior to discharge, followed by 50 mg doses taken orally every 12 hours for 5 days, totaling 11 doses.
  • Drug Acetaminophen
    As part of the multimodal pain regimen, participants will also receive acetaminophen (Tylenol) (500 mg, every 4 hours, or 1000 mg, every 8 hours)

Primary outcome measures

  • Postoperative pain [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

  • Aged 40-80 years.
  • Undergoing thumb basal joint arthroplasty (BJA)
  • Able to provide informed consent.
  • Willing to comply with the study procedures.

Exclusion criteria

  • History of substance abuse or chronic opioid use.
  • Known allergies to acetaminophen, oxycodone, or suzetrigine.
  • Severe renal or hepatic dysfunction
  • Estimated glomerular filtration rate less than 15 ml/min/1.73m\^2
  • History of kidney transplant
  • Child-Pugh Class C
  • History of liver failure
  • Active hepatitis that can adversely influence hepatic function
  • Has had prior surgery on the study hand within the last 6 months
  • Is currently pregnant, planning to be pregnant, or breastfeeding
  • Use of strong or moderate CYP3A inhibitors or inducers, or medications known to interact with suzetrigine
  • Currently using a prescription pain medication other study medications

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Rothman Orthopaedic Institute — Philadelphia

Identifiers

NCT: NCT07723352 · AILY2025-1283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗