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Набор скоро начнётся NCT07349082

Sensory Block Onset: Epidural vs Dural Puncture Epidural in Cesarean Section

Без фазы С лечением Cesarean Section

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: Dural Puncture Epidural (DPE) Anesthesia, epidural anesthesia.
Кому может быть актуально
Состояния в реестре: Cesarean Section. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индонезия
Следующий шаг
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Официальное название

Comparison of Sensory Block Onset Time Between Epidural and Dural Puncture Epidural (DPE) Anesthesia for Cesarean Delivery: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing elective cesarean delivery. The study also aims to evaluate hemodynamic stability and procedure-related side effects associated with both techniques. The main questions it aims to answer are: 1. What is the difference in the onset of sensory block between epidural anesthesia and dural puncture epidural (DPE) in patients undergoing cesarean section? 2. Are there differences in hemodynamic stability between epidural anesthesia and DPE during surgery? 3. What procedure-related side effects occur with each anesthetic technique? Researchers will compare epidural anesthesia with dural puncture epidural (DPE) to determine which technique achieves a faster and more effective sensory block while maintaining maternal hemodynamic stability. Participants will: 1. Be randomly assigned to receive either epidural anesthesia or DPE anesthesia 2. Undergo elective cesarean delivery under regional anesthesia 3. Have sensory block onset, hemodynamic parameters, and adverse events monitored and recorded intraoperatively

Вмешательства

  • Процедура Dural Puncture Epidural (DPE) Anesthesia
    Dural puncture epidural (DPE) is a combined neuraxial technique that integrates spinal and epidural approaches to enhance the quality of sensory and motor blockade. The procedure begins with dural puncture using a 26-gauge Spinocan spinal needle at the L3-L4 lumbar interspace until cerebrospinal fluid (CSF) is observed, indicating a micro-dural lesion, after which the spinal needle is withdrawn. Subsequently, an epidural catheter is inserted using an 18-gauge Tuohy needle with the loss-of-resist
  • Процедура epidural anesthesia
    Conventional epidural technique for elective cesarean delivery. Epidural anesthesia is a neuraxial technique used for analgesia or anesthesia during cesarean delivery by administering local anesthetic agents through a catheter placed in the epidural space without penetrating the dura mater. In this study, epidural anesthesia is operationalized by inserting an 18-gauge Tuohy needle at the L3-L4 lumbar interspace, advancing the epidural catheter 4-5 cm into the epidural space, followed by administ

Первичные конечные точки

  • Time (minutes) to achieve bilateral T6 sensory block [Срок оценки: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period).]
  • Time (minutes) to achieve Bromage grade 3 motor block [Срок оценки: From an anesthetic injection to the achievement of sensory and motor block during surgery (intraoperative period)]
Вторичные конечные точки (6)
  • Mean Arterial Pressure (MAP) [Срок оценки: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery]
  • Heart Rate (HR) [Срок оценки: From baseline (minute 0) to 20 minutes after anesthetic administration during surgery]
  • Number of participants with Post-dural Puncture Headache (PDPH) [Срок оценки: Within 72 hours after neuraxial anesthesia]
  • Number of participants with nausea and/or vomiting [Срок оценки: During anesthetic administration and surgery]
  • APGAR Score [Срок оценки: At 1 and 5 minutes after birth]
  • Number of participants with hypotension [Срок оценки: From anesthetic administration until the end of surgery]

Критерии участия

Критерии включения

  • Pregnant women scheduled to undergo cesarean delivery
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Willing to participate in the study by providing written informed consent

Критерии исключения

  • Patients with absolute contraindications to neuraxial anesthesia
  • Patients with known allergy or history of allergy to medications used in the study
  • Patients with psychiatric disorders or who are uncooperative
  • Patients with accidental dural puncture

Dropout Criteria:

  • Patients who require conversion to general anesthesia during the procedure
  • Patients who experience major intraoperative complications (massive hemorrhage, shock, or cardiac arrest)

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
Простое слепое
Основная цель
Лечение

Центры проведения

Индонезия · 2 центра
  • Dr. Sardjito General Hospital — Sleman
  • Persahabatan General Hospital — Jakarta

Идентификаторы

NCT: NCT07349082 · NaufalRCT1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗