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Journavx to Treat Pain After Thumb Basal Joint Arthroplasty

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07723352
Enrollment
100
Registered
2026-07-23
Start date
2026-07-21
Completion date
2028-12-31
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

DRUGAcetaminophen

As part of the multimodal pain regimen, participants will also receive acetaminophen (Tylenol) (500 mg, every 4 hours, or 1000 mg, every 8 hours)

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain5 daysParticipants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals

Countries

United States

Contacts

STUDY_DIRECTORCamilo Restrepo, MD

Rothman Orthopaedic Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026