The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction
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: perineural Dexamethasone, intravenous Dexamethasone.
- Кому может быть актуально
- Состояния в реестре: Scoliosis Idiopathic Adolescent. Базовые параметры: 10 лет — 18 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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Обзор
Scoliosis correction surgery in children is a complex procedure with significant risks, including postoperative pain, inflammatory response, and potential neurological complications. Effective pain control and minimizing inflammation are critical for faster recovery and improved patient outcomes. Dexamethasone is commonly used as an adjuvant in regional anesthesia due to its anti-inflammatory effects and ability to prolong analgesia. However, limited research exists on the optimal route of dexamethasone administration (intravenous vs. perineural) and the best local anesthetic concentration for pain management, inflammatory response, and neuromonitoring during surgery. This study aims to compare the effects of different dexamethasone administration routes and local anesthetic concentrations on postoperative pain, inflammation (NLR, PLR), and neuromonitoring in pediatric scoliosis surgery. Results may improve regional anesthesia protocols, enhance patient safety, and offer valuable insights for clinical practice.
Подробное описание
Scoliosis correction surgery in children is a complex procedure associated with a significant risk of postoperative pain, inflammatory response, and potential neurological complications. Ensuring optimal pain control and minimizing adverse inflammatory responses is crucial for shortening the recovery period, improving patient comfort, and reducing the risk of long-term complications. In clinical practice, dexamethasone is frequently used as an adjuvant in regional anesthesia techniques due to its anti-inflammatory properties and its potential to prolong the analgesic effect.
Although the use of dexamethasone as an adjuvant in regional anesthesia is well known, there is limited research focusing on the impact of its route of administration (local versus intravenous) and the optimal concentration of local anesthetic agents on the effectiveness of pain control, inflammatory response, and neuromonitoring parameters during surgical procedures in children. Understanding these aspects is particularly important in complex procedures such as scoliosis correction surgery, where precise neurological function monitoring is essential for patient safety.
The objective of the proposed study is to evaluate the impact of different dexamethasone administration routes (intravenous and perineural) and varying concentrations of local anesthetic agents on postoperative pain, inflammatory response (measured using NLR and PLR indices), and neuromonitoring parameters in children undergoing scoliosis correction surgery. The findings from this study may contribute to the development of more effective and safer regional anesthesia and analgesia protocols for this patient group.
Conducting this study will provide new insights into the optimization of anesthesia in pediatric spinal surgery, potentially leading to improved treatment outcomes and patient safety, as well as valuable data for clinical practice regarding the selection of anesthetic strategies.
Вмешательства
- Препарат perineural Dexamethasone
Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg perineural Dexamethasone - Препарат intravenous Dexamethasone
Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg intravenous Dexamethasone
Первичные конечные точки
- Time to first rescue opioid analgesia [Срок оценки: 48 hours after surgery]
Вторичные конечные точки (12)
- intraoperative requirement for propofol [Срок оценки: durring surgery]
- intraoperative requirement for remifentanil [Срок оценки: durring surgery]
- MEP [Срок оценки: durring surgery]
- Total opioid consumption [Срок оценки: 48 after surgery]
- NRS [Срок оценки: 6 hours after surgery]
- NRS [Срок оценки: 12 hours after surgery]
- NRS [Срок оценки: 24 hours after surgery]
- NRS [Срок оценки: 36 hours after surgery]
- NRS [Срок оценки: 48 hours after surgery]
- NLR [Срок оценки: 12 hours after surgery]
- NLR [Срок оценки: 48 hours after surgery]
- PLR [Срок оценки: 12 hours after surgery]
Критерии участия
Критерии включения
- >10 and <18 years old
- scheduled for idiopathic scoliosis surgery
Критерии исключения
- included infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
- American Society of Anesthesiologists (ASA) physical status of IV or higher,
- history of regular steroid medication.
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: NCT06789029 · 1/2025