Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women

Официальное название

Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Multiparous Women. A Randomized Controlled Trial

Обзор

The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in multiparous women compared to continuous epidural infusion. multiparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

Подробное описание

There are several pharmacological and non-pharmacological techniques for pain relief during labor. Epidural analgesia is considered the most effective modality for intrapartum pain relief.

Maintenance of epidural analgesia is achieved by different techniques; continuous epidural infusion (CEI), intermittent epidural analgesia (IEA), patient control epidural analgesia (PCEA) and combination between the techniques.

Another technique, the Programmed Intermittent Bolus Epidural Analgesia (PIBEA). The advantage of this technique is that boluses are given all the time at planned intervals, so laboring women do not depend on the medical staff to receive the bolus when there is a breakthrough pain.

This method has been reported to be associated with less motor block, lower incidence of instrumental vaginal deliveries, and less consumption of anesthetic agents when compared to CEI. There are no conclusive data regarding the use of PIBEA in combination with PCEA compared to CEI and PCEA on the effect of pain relief during labor and birth outcomes. The hypothesis of the current trial is that PIBEA and PCEA will decrease the incidence of breakthrough pain, and probably shorten the second stage of labor, lead to fewer instrumental deliveries and higher women's satisfaction compared to CEI and PCEA.

Вмешательства

• Препарат programmed intermittent Bolus epidural analgesia
  About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score \<30, the woman will receive the study group protocol for pain maintenance, i.e., a programmed intermittent bolus of 10 ml of 0.1% bupivacaine and 2 μg/ml fentanyl every hour until the completion of labor and suturing of the incision. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The
• Препарат continuous epidural infusion
  About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score \<30, the woman will receive the control group protocol for pain maintenance, i.e., 0.1% Bupivacaine and 2 μg/ml fentanyl as a continuous infusion per one hour, until the delivery is completed, and laceration is sutured. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose t

Первичные конечные точки

• breakthrough pain [Срок оценки: 48 hours]

Вторичные конечные точки (12)

• manual bolus (top up) [Срок оценки: 48 hours]
• Hourly visual analogue scale [Срок оценки: 48 hours]
• Time to delivery [Срок оценки: 48 hours]
• Oxytocin augmentation [Срок оценки: 48 hours]
• Duration of second stage [Срок оценки: 48 hours]
• Intrapartum fever [Срок оценки: 48 hours]
• Number of patients that will require use of intrapartum use of antibiotic treatment [Срок оценки: 48 hours]
• Mode of delivery [Срок оценки: 48 hours]
• Indications for cesarean or operative vaginal deliveries [Срок оценки: 48 hours]
• duration of third stage [Срок оценки: 48 hours]
• Early postpartum hemorrhage (PPH) [Срок оценки: 48 hours]
• Hemoglobin level [Срок оценки: 96 hours]

Критерии участия

Критерии включения

• multiparous women
• Term pregnancy
• Singleton
• Vertex presentation
• Latent phase (cervical dilatation less than 6 cm)
• Epidural analgesia request
• Visual Analogue Scale score greater than 40

Критерии исключения

• Estimated fetal weight greater than 4.0 kg
• Intra uterine fetal death
• Drug sensitivity

5\. Anomalous fetus 6. Contraindication for epidural analgesia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Израиль · 1 центр

• Holy Family Hospital — Nazareth

Идентификаторы

NCT: NCT06580327 · 298\2024 HFH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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