Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty

Обзор

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.

Подробное описание

The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty.

The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.

Вмешательства

• Препарат Suzetrigine
  Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons.

Первичные конечные точки

• Mean pain intensity score on the Numeric Rating Scale (NRS) [Срок оценки: Day 0-14 postoperative]
• Average daily opioid consumption [Срок оценки: Day 0-14 postoperative]
• Cumulative opioid consumption [Срок оценки: 3 weeks and 3 months postoperative]

Вторичные конечные точки (7)

• Nausea scores postoperative [Срок оценки: Day 0-14 post-operative]
• Total sleep time [Срок оценки: Day 0-14 post-operative]
• Sleep efficiency [Срок оценки: Day 0-14 post-operative]
• Sleep latency [Срок оценки: Day 0-14 post-operative]
• Wake after sleep onset (WASO) [Срок оценки: Day 0-14 post-operative]
• EQ5D Score [Срок оценки: 3 months post-operative]
• KOOS Jr Score [Срок оценки: Baseline, 3 months post-operative]

Критерии участия

Критерии включения

• Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
• Patients between the ages of 18 and 95 years.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Emory Clinic — Atlanta
• Emory Clinic at Executive Park — Atlanta
• Emory Orthopaedics and Spine Center — Atlanta

Идентификаторы

NCT: NCT07624526 · 2026P000242

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗