Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Multiparous Women. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- breakthrough pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •multiparous women
- •Term pregnancy
- •Vertex presentation
- •Latent phase (cervical dilatation less than 6 cm)
- •Epidural analgesia request
- •Visual Analogue Scale score greater than 40
排除标准
- •Estimated fetal weight greater than 4.0 kg
- •Intra uterine fetal death
- •Drug sensitivity
- •5. Anomalous fetus
- •Contraindication for epidural analgesia
研究组 & 干预措施
study group
Epidural analgesia will be maintained by receiving programmed intermittent 10ml bolus of 0.1% Bupivacaine and 2microgram\ml Fentanyl every one hour, until the delivery is completed, and lacerations are sutured.
干预措施: programmed intermittent Bolus epidural analgesia (Drug)
control group
Epidural analgesia will be maintained by receiving 10ml\h continuous infusion of 0.1% Bupivacaine and 2microgram\ml Fentanyl until the delivery is completed, and lacerations are sutured.
干预措施: continuous epidural infusion (Drug)
结局指标
主要结局
breakthrough pain
时间窗: 48 hours
Incidence of breakthrough pain, defined as Visual Analogue Scale (VAS) score \> 30. The VAS consists of a 100cm line, with two end points representing 0 ('no pain') and 100 (severe pain).
次要结局
- manual bolus (top up)(48 hours)
- Hourly visual analogue scale(48 hours)
- Time to delivery(48 hours)
- Oxytocin augmentation(48 hours)
- Duration of second stage(48 hours)
- Intrapartum fever(48 hours)
- Number of patients that will require use of intrapartum use of antibiotic treatment(48 hours)
- Mode of delivery(48 hours)
- Indications for cesarean or operative vaginal deliveries(48 hours)
- duration of third stage(48 hours)
- Early postpartum hemorrhage (PPH)(48 hours)
- Hemoglobin level(96 hours)
- Blood transfusion(72 hours)
- Obstetric anal sphincter injury(48 hours)
- Motor block of any leg(48 hours)
- Urinary retention(48 hours)
- Dural puncture(48 hours)
- Side effects related epidural analgesia use(48 hours)
- mean arterial blood pressure(48 hours)
- systolic blood pressure < 90mmHg(48 hours)
- Bupivacaine consumption(48 hours)
- maternal satisfaction(48 hours)
- fetal cord artery pH(48 hours)
- meconium staining(48 hours)
- Neonatal sepsis(72 hours)
- Apgar score (0 to 10)(48 hours)
研究者
Raed Salim, MD
head of obstetrics and gynecology department
Holy Family Hospital, Nazareth, Israel