Идёт набор NCT07474909

Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery

Без фазы С лечением Hand Injuries and Disorders Wrist Sprain

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: iv dexamethasone, pn dexamethasone, 0.9%NaCl.
Кому может быть актуально: Состояния в реестре: Hand Injuries and Disorders, Wrist Sprain. Базовые параметры: 3 мес. — 16 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

Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment

Обзор

This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients. All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups: perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period. This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.

Подробное описание

Regional anesthesia using brachial plexus block is routinely used for pediatric upper limb surgery, but the long-term neurological safety of perineural dexamethasone remains uncertain. Previous adult studies and early pilot investigations suggest that dexamethasone increases the duration of analgesia and may reduce opioid requirements, but pediatric data remain scarce.

This randomized double-blind placebo-controlled clinical trial will compare three approaches:

perineural dexamethasone, intravenous dexamethasone, placebo. Neurological integrity will be evaluated using structured neurological examinations and serial measurement of serum neurofilament light chain (NfL), a biomarker of peripheral nerve damage. Functional recovery, pain scores, opioid use, and adverse events will also be assessed. Each patient will be followed for 12 months.

The results may guide pediatric regional anesthesia practice and help determine whether perineural dexamethasone is safe with regard to neurologic sequelae.

Вмешательства

Препарат iv dexamethasone
Participants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg/kg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.
Препарат pn dexamethasone
Participants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg/kg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.
Препарат 0.9%NaCl
Participants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.

Первичные конечные точки

Incidence of Persistent Neurological Deficit [Срок оценки: up to 12 months]

Вторичные конечные точки (12)

Time to First rescue analgesia [Срок оценки: Within 0-48 hours after surgery.]
Total Opioid Consumption [Срок оценки: 0-48 hours after surgery.]
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Post-anesthesia care unit (PACU), 2 hours after surgery.]
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Post-anesthesia care unit (PACU), 6 hours after surgery.]
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Post-anesthesia care unit (PACU), 12 hours after surgery.]
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Post-anesthesia care unit (PACU), 24 hours after surgery.]
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: Post-anesthesia care unit (PACU), 48 hours after surgery.]
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Срок оценки: Post-anesthesia care unit (PACU), 2 hours after surgery.]
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Срок оценки: Post-anesthesia care unit (PACU), 6 hours after surgery.]
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Срок оценки: Post-anesthesia care unit (PACU), 12 hours after surgery.]
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Срок оценки: Post-anesthesia care unit (PACU), 24 hours after surgery.]
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS) [Срок оценки: Post-anesthesia care unit (PACU), 48 hours after surgery.]

Критерии участия

Критерии включения

Age 3 months to 16 years
Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
ASA physical status I-III
Planned use of ultrasound-guided regional anesthesia
Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child