Journavx to Treat Pain After Thumb Basal Joint Arthroplasty

N/AEnrolling By InvitationNCT07723352

Rothman Institute Orthopaedics100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Thumb Basal Joint Osteoarthritis Postoperative Pain Joint Replacement Surgery Joint Replacement

Interventions

suzetrigine 100mgDRUG

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.

AcetaminophenDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Postoperative pain

Participants Pain will be assessed using the Numeric Rating Scale (NRS)at regular daily postoperative intervals

Time frame: 5 days

Data from ClinicalTrials.gov

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