Идёт набор NCT07395934

Comparing PIEB and CEI for Labor Pain Relief

Без фазы С лечением Labor Pain Analgesia, Epidural Analgesia, Obstetrical Labor, Obstetric

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: PIEB + PCEA, CEI + PCEA.
Кому может быть актуально: Состояния в реестре: Labor Pain, Analgesia, Epidural, Analgesia, Obstetrical, Labor, Obstetric. Базовые параметры: 18 лет — 40 лет · 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: Вьетнам
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 Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial

Обзор

The purpose of this randomized controlled trial is to compare the efficacy and safety of two epidural analgesia maintenance methods for labor pain relief: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). The study aims to evaluate which technique provides superior analgesia while minimizing anesthetic consumption and preserving maternal motor function. A total of 60 parturients at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group. Outcomes including pain intensity (VAS scores), total drug consumption, maternal satisfaction, and neonatal Apgar scores will be assessed.

Подробное описание

This study is a prospective, randomized controlled trial conducted at the Labor and Delivery Unit of Family Hospital, Da Nang. The investigation focuses on the clinical advantages of automated high-pressure bolus delivery (PIEB) compared to constant low-pressure flow (CEI) in optimizing the spread of local anesthetics within the epidural space.

Clinical Procedures: All participants receive a standardized initial manual bolus of 10 mL (0.1% Ropivacaine and 2 mcg/mL Fentanyl) to establish a baseline sensory block. Following this induction, patients are managed according to their assigned study arm:

PIEB Group: Analgesia is maintained using a programmed pump set to deliver an automated bolus of 8 mL every 60 minutes, starting one hour after the initial dose.

CEI Group: Analgesia is maintained via a continuous infusion of the same anesthetic solution at a constant rate of 8 mL/hour.

Analgesia Management and Rescue Protocol: Both groups have access to PCEA, allowing for self-administered 5 mL boluses with a 10-minute lockout period, capped at a maximum of 20 mL per hour.

To ensure maternal comfort, a standardized rescue protocol is strictly followed: if the Visual Analog Scale (VAS) score remains \> 4 after two consecutive PCEA demands, a manual rescue bolus of 5 mL is administered by the anesthesia team.

Вмешательства

Процедура PIEB + PCEA
Initial dose: 10 mL (0.1% Ropivacaine + 2 mcg/mL Fentanyl). Maintenance: 8 mL bolus every 60 mins. PCEA: 5 mL bolus, 10-min lockout.
Процедура CEI + PCEA
Initial dose: 10 mL (0.1% Ropivacaine + 2 mcg/mL Fentanyl). Maintenance: Continuous infusion at 8 mL/hour. PCEA: 5 mL bolus, 10-min lockout.

Первичные конечные точки

Labor Pain Intensity [Срок оценки: Baseline (prior to epidural analgesia induction), then at 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours after the initiation of analgesia. Additional assessments are performed at full cervical dilation, during the fetal expulsion stage]

Вторичные конечные точки (4)

Total Ropivacaine Consumption [Срок оценки: From the initiation of epidural analgesia until the completion of perineal repair, assessed up to 24 hours.]
Incidence of Maternal Motor Block [Срок оценки: From the initiation of epidural analgesia, assessed at 5, 10, 30, 60 minutes, then every 2 hours until the completion of perineal repair (assessed up to 24 hours).]
Maternal Satisfaction Score [Срок оценки: At 2 hours after the completion of perineal repair (assessed up to 24 hours after enrollment).]
Neonatal Apgar Scores [Срок оценки: At 1 minute and 5 minutes post-delivery.]

Критерии участия

Критерии включения

Parturients indicated for labor analgesia for vaginal delivery via epidural anesthesia.
Age from 18 to 40 years.
Physical status: ASA II.
Singleton pregnancy, full-term, vertex presentation in labor.
Indication for vaginal delivery.
No contraindications to epidural anesthesia.
Agreement to participate in the research and signed written informed consent.