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Orthopédie sans opioïdes

10 novembre 2026 mis à jour par: Eric Wagner, Emory University

Un essai contrôlé randomisé en double aveugle examinant les procédures orthopédiques multimodales sans opioïdes

The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • Phase 3

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.

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Emory University Hospital
      • Atlanta, Georgia, États-Unis, 30029
        • The Emory Clinic
      • Tucker, Georgia, États-Unis, 30084
        • Emory Orthopedic and Spine Hospital

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
  • Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
  • Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
  • Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
  • Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Exclusion Criteria:

  • Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
  • Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
  • Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Opioid Group

Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Médicament: Oxycodone 5 mg Oral Tablet

Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
Expérimental: Placebo Group

Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Médicament: Placebo oral tablet

Encapsulated placebo tablets x24, to take po q6 hours as need for pain

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Pain (VAS) Score
Délai: Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative

The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months and 24 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative Opioid Consumption
Délai: Postoperative Days 1-14

Total opioid consumption in Morphine milligram equivalents (MME) during the first 2 weeks after surgery will be measured.
Postoperative Days 1-14
Number of participants that required Rescue Opioid Prescription
Délai: Postoperative Days 1-14

Number of participants that required the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.
Postoperative Days 1-14
Number of tables consumed as Rescue Opioid
Délai: Postoperative Days 1-14

Number of tablets taken from the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.
Postoperative Days 1-14
Number of Additional Opioid Prescription Refills
Délai: Postoperative Days 1-14

Number of additional opioid prescription refills required during the postoperative period.
Postoperative Days 1-14
Number of participants experiencing Postoperative Nausea
Délai: Three times a day postoperatively for the first 2 weeks

Number of participants experiencing nausea during the postoperative period. This scale will assess nausea at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The scale will range from 0-10 with 10 being a worse outcome quantifying the highest nausea rating.
Three times a day postoperatively for the first 2 weeks
Hand/Wrist function Measured by the Single Assessment Numeric Evaluation (SANE)
Délai: Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.

The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. A rating of 0 is the minimum value and denotes the worse outcome a patient can have on the scale.
Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
Upper Extremity Function Measured by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Délai: Baseline (Preoperative); and at 12 and 24 months postoperatively.

Upper extremity disability will be assessed using the QuickDASH questionnaire. Scores range from 0 to 100, with lower scores indicating less disability.
Baseline (Preoperative); and at 12 and 24 months postoperatively.
Overall Satisfaction with the procedure and Pain Management
Délai: 12 and 24 months postoperatively

Overall satisfaction with the surgical procedure and postoperative pain management will be assessed using a patient-reported 5-point rating scale. Participants will select one of the following responses: "Very satisfied", "satisfied", "neutral", "dissatisfied", and "Very dissatisfied".

Responses are assigned a score from 1 to 5, where 1 corresponds to "very dissatisfied" and 5 corresponds to "very satisfied". Higher scores indicate greater satisfaction and better perceived outcomes
12 and 24 months postoperatively
Willingness to undergo the same procedure with the same pain management
Délai: 12 and 24 months postoperatively

Number of Participants that confirm their willingness to undergo the same procedure again using the same postoperative pain management regimen.
12 and 24 months postoperatively
Number of participants Experiencing Major Postoperative Complications
Délai: From surgery through 24 months postoperatively

Number of participants experiencing one or more major postoperative complications, including temporary or permanent nerve injury, hematoma, superficial or deep infection, recurrent moderate or severe pain, fracture, implant loosening, dislocation, or revision surgery.
From surgery through 24 months postoperatively

Collaborateurs et enquêteurs

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

Parrainer

Emory University

Les enquêteurs

  • Chercheur principal: Eric Wagner, 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 (Réel)

11 décembre 2020

Achèvement primaire (Réel)

20 juillet 2026

Achèvement de l'étude (Réel)

20 juillet 2026

Dates d'inscription aux études

Première soumission

30 novembre 2020

Première soumission répondant aux critères de contrôle qualité

7 décembre 2020

Première publication (Réel)

9 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY00000478

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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