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

28 mai 2026 mis à jour par: Ajay Premkumar, Emory University
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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

75

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Emory Clinic
      • Atlanta, Georgia, États-Unis, 30329
        • Emory Clinic at Executive Park
      • Atlanta, Georgia, États-Unis, 30329
        • Emory Orthopaedics and Spine Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Autres noms:
  • JOURNAVX®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean pain intensity score on the Numeric Rating Scale (NRS)
Délai: Day 0-14 postoperative
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.
Day 0-14 postoperative
Average daily opioid consumption
Délai: Day 0-14 postoperative
Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
Day 0-14 postoperative
Cumulative opioid consumption
Délai: 3 weeks and 3 months postoperative
Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
3 weeks and 3 months postoperative

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Nausea scores postoperative
Délai: 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.
Day 0-14 post-operative
Total sleep time
Délai: Day 0-14 post-operative
Total sleep time will be collected using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Sleep efficiency
Délai: Day 0-14 post-operative
Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Sleep latency
Délai: Day 0-14 post-operative
Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
Wake after sleep onset (WASO)
Délai: Day 0-14 post-operative
Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
Day 0-14 post-operative
EQ5D Score
Délai: 3 months post-operative
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).
3 months post-operative
KOOS Jr Score
Délai: Baseline, 3 months post-operative
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.
Baseline, 3 months post-operative

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emory University

Collaborateurs

Vertex Pharmaceuticals Incorporated

Les enquêteurs

  • Chercheur principal: Ajay Premkumar, MD, Emory University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

28 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026P000242

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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