Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Darrell Favors
- Número de teléfono: 404-313-3276
- Correo electrónico: darrell.favors@emory.edu
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory Clinic
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Atlanta, Georgia, Estados Unidos, 30329
- Emory Clinic at Executive Park
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Atlanta, Georgia, Estados Unidos, 30329
- Emory Orthopaedics and Spine Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Suzetrigine Regimen Arm
Suzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days. The starting dose will be 100 mg orally taken as two 50 mg tablets on an empty stomach (at least 1 hour before or 2 hours after food). Maintenance dosing will begin 12 hours after the initial dose, at which point patients will take 50 mg orally every 12 hours. |
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean pain intensity score on the Numeric Rating Scale (NRS)
Periodo de tiempo: Day 0-14 postoperative
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Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain).
Higher score correlates with worse outcome.
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Day 0-14 postoperative
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Average daily opioid consumption
Periodo de tiempo: Day 0-14 postoperative
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Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
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Day 0-14 postoperative
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Cumulative opioid consumption
Periodo de tiempo: 3 weeks and 3 months postoperative
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Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
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3 weeks and 3 months postoperative
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nausea scores postoperative
Periodo de tiempo: Day 0-14 post-operative
|
A nausea assessment will be assessed using the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea).
Patients will be asked to fill out the VAS-nausea each day until post-operative day 14.
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Day 0-14 post-operative
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Total sleep time
Periodo de tiempo: Day 0-14 post-operative
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Total sleep time will be collected using actigraphy during postoperative days 0-14.
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Day 0-14 post-operative
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Sleep efficiency
Periodo de tiempo: Day 0-14 post-operative
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Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.
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Day 0-14 post-operative
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Sleep latency
Periodo de tiempo: Day 0-14 post-operative
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Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
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Day 0-14 post-operative
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Wake after sleep onset (WASO)
Periodo de tiempo: Day 0-14 post-operative
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Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
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Day 0-14 post-operative
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EQ5D Score
Periodo de tiempo: 3 months post-operative
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Health-related quality of life measure using the EQ-5D questionnaire, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Responses are converted into a summary index score, where 1 represents full health and 0 represents death (higher values indicating better health status).
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3 months post-operative
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KOOS Jr Score
Periodo de tiempo: Baseline, 3 months post-operative
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Patient-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS Jr).
The KOOS Jr is a validated short-form instrument derived from the full KOOS, designed to evaluate knee health based on key items related to pain, symptoms, and physical function.
Scores are transformed to a 0 to 100 scale, with higher scores indicating better knee function and fewer symptoms.
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Baseline, 3 months post-operative
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ajay Premkumar, MD, Emory University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026P000242
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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