Journavx to Treat Pain After Thumb Basal Joint Arthroplasty

NCT07723352 | Enrolling By Invitation FDA Drug

• 1 other identifier: AILY2025-1283
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

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

  5 days

Study Arms (1)

Participants undergoing thumb Basal Joint Replacement Surgery

Participants undergoing thumb Basal Joint Replacement Surgery receive suzetrigine (100 mg loading dose followed by 50 mg every 12 hours for 5 days) in combination with acetaminophen (Tylenol).

Drug: suzetrigine 100mg; Drug: Acetaminophen

Interventions

suzetrigine 100mg DRUG

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.

Participants undergoing thumb Basal Joint Replacement Surgery

Acetaminophen DRUG

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

Participants undergoing thumb Basal Joint Replacement Surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants Undergoing thumb basal joint arthroplasty (BJA) at Rothman Orthopaedic Institute

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Camilo Restrepo, MD

  Rothman Orthopaedic Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)