Role of Suzetrigine as a Part of a Multimodal Regimen to Red... | Clinical Trial | StuddyBuddy@endsection
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NCT07624526
Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
Conditions: Knee Arthritis, Knee Osteoarthritis
Sex: All
Ages: 18 Years – 95 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 75
Sponsor: Emory University
Location: Emory Clinic Atlanta Georgia
Summary
This study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of care.
Eligibility Criteria
Inclusion Criteria:
* Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
* Patients between the ages of 18 and 95 years.
Exclusion Criteria:
* Patients with concurrent and significant injuries to other bones or organs.
* Patients with local infections.
* Minors unable to provide informed consent for participation in the study.
* Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
* Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
* Patients with preoperative opioid use, defined as daily use less than 4 weeks before the index surgery.
* Patients with a history of severe heart disease (NYHA2), renal failure, or liver dysfunction
* Patients with active peptic ulcer disease.
* Patients neurological or psychiatric diseases, potentially influencing pain perception
* Patients who are pregnant.
* Patients with a history of alcohol or medical abuse, allergies to glucocorticoids, current daily use of glucocorticoids.
* Patients who are unable to take NSAIDs.
* Patients who receive Deep Venous Thrombosis (DVT) prophylaxis different than Aspirin (81mg) twice daily (BID).
* Patients who have known diabetes mellitus as defined with an A1C greater than 6.5%.
* Patients currently taking CYP3A inhibitors
Source: ClinicalTrials.gov (NCT07624526). StuddyBuddy aggregates publicly available trial information.