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Идёт набор NCT06780202

Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients

Фаза II С лечением Foot Injuries and Disorders Ankle Injuries and Disorders Achilles Tendon Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: medrol dosepak, HYDROcodone Oral Tablet.
Кому может быть актуально
Состояния в реестре: Foot Injuries and Disorders, Ankle Injuries and Disorders, Achilles Tendon Injury. Базовые параметры: 18 лет — 95 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries. The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

Подробное описание

The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.

This has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.

A recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.

Based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment

Вмешательства

  • Препарат medrol dosepak
    Methylprednisolone is a corticosteroid with anti-inflammatory properties and immune suppression. This study will utilize a 6-day Medrol Dosepak: a tapered low-dose corticosteroid course taken orally once a day. This includes 6 tablets on day 1 (24 mg), 5 tablets on day 2 (20 mg), 4 tablets on day 3 (16 mg), 3 tablets on day 4 (12 mg), 2 tablets on day 5 (8 mg) and 1 tablet on day 6 (4 mg).
  • Препарат HYDROcodone Oral Tablet
    This study will utilize a prescription of 20 pills of hydrocodone, 5mg each, to be taken as needed for pain, 1 every 6 hours.

Первичные конечные точки

  • Post operative Nausea [Срок оценки: Baseline (Day 0), 7 days post op]
  • Post operative pain [Срок оценки: Baseline, 0.25 months, 1.5 months, 3 months, 6 months]
  • Post operative opioid consumption [Срок оценки: Baseline (Day 0), 7 days post op]
Вторичные конечные точки (2)
  • Complications due to the Medrol Dosepak [Срок оценки: 1.5 months, 3 months, 6 months]
  • Patient reported outcomes [Срок оценки: Baseline (pre operative assessment), Post operation (6 months)]

Критерии участия

Критерии включения

-Emory Orthopedic patients undergoing foot and ankle surgery

Критерии исключения

  • Concurrent or significant injuries to other bones or organs
  • Local infections
  • History of alcohol or medical abuse, including prior opioid abuse
  • Smoking
  • History of severe heart disease, renal failure, liver dysfunction, active peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that could influence pain perception
  • Pre-existing immune suppression
  • Those deemed possibly non-compliant by the study team and,
  • All vulnerable populations (those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-English speaking).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Emory Musculoskeletal Institute, Emory Orthopaedics & Spine Center — Atlanta
  • Emory Sports Medicine Complex and Emory Orthopaedics and Spine Center — Johns Creek

Идентификаторы

NCT: NCT06780202 · STUDY00008454 · 2025P009012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗