Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial
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: Dexamethasone 4mg, Placebo, Dexamethasone 8mg.
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis, Hip, Hip Osteoarthritis. Базовые параметры: 18 лет — 100 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
- Польша
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Обзор
his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.
Подробное описание
Effective pain control after total hip arthroplasty (THA) remains a key component of perioperative care, as inadequate analgesia may delay mobilization, prolong hospital stay, and increase the need for opioids. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, are increasingly used to improve postoperative pain management while preserving motor function.
Dexamethasone administered intravenously is commonly used in perioperative care, primarily for the prevention of postoperative nausea and vomiting. In addition, it has been shown to prolong the duration of analgesia when used as an adjunct to regional anesthesia. However, there is still uncertainty regarding the optimal intravenous dose that provides clinically meaningful analgesic benefit without increasing the risk of adverse effects, particularly hyperglycemia.
Previous studies have typically used doses ranging from 4 mg to 8 mg, but direct comparisons between these doses, as well as comparison with placebo, remain limited in patients undergoing THA. Furthermore, the potential dose-response relationship of intravenous dexamethasone in this specific surgical population has not been clearly established.
This study is designed to address this knowledge gap by evaluating whether intravenous dexamethasone provides additional analgesic benefit in patients undergoing THA with PENG block, and whether higher doses result in improved outcomes compared to lower doses or no dexamethasone. The findings may help optimize perioperative analgesic strategies and support more evidence-based dosing of dexamethasone in orthopedic surgery.
Вмешательства
- Препарат Dexamethasone 4mg
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg - Препарат Placebo
Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia. - Препарат Dexamethasone 8mg
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg
Первичные конечные точки
- Time to First Rescue Analgesia [Срок оценки: 48 hours after surgery]
Вторичные конечные точки (11)
- Postoperative Pain Intensity [Срок оценки: 6 hours after surgery]
- Postoperative Pain Intensity [Срок оценки: 12 hours after surgery]
- Postoperative Pain Intensity [Срок оценки: 24 hours after surgery]
- Postoperative Pain Intensity [Срок оценки: 48 hours after surgery]
- Opioid Consumption [Срок оценки: 48 hours after surgery]
- Opioid Consumption [Срок оценки: 24 hours after surgery]
- Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: 24 hours after surgery]
- Blood Glucose Levels [Срок оценки: immidietly after surgery (0 hours after surgery)]
- Blood Glucose Levels [Срок оценки: 6 hours after surgery]
- Blood Glucose Levels [Срок оценки: 12 hours after surgery]
- Blood Glucose Levels [Срок оценки: 24 hours after surgery]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Scheduled for elective total hip arthroplasty (THA)
- Planned use of regional anesthesia including PENG block
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
- Ability to assess pain using the Numeric Rating Scale (NRS)
Критерии исключения
- Known hypersensitivity to dexamethasone or any component of the study medication
- Chronic corticosteroid therapy or use of systemic steroids within 14 days prior to surgery
- Active systemic infection or sepsis
- Significant immunosuppression (e.g., chemotherapy, biological therapy)
- Pregnancy or breastfeeding
- Severe cognitive impairment or inability to reliably assess pain
- Uncontrolled diabetes mellitus (e.g., HbA1c > 8.5% or baseline blood glucose > 200 mg/dL)
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Польша · 1 центр
- Poznan University of Medical Sciences — Poznan
Идентификаторы
NCT: NCT07581470 · 3/2026