Pain Management During Labor: Use of Intermittent Drug Delivery Devices for Obstetric and Neonatal Outcome Improvement and Health-care Burden Reduction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 671
- 试验地点
- 3
- 主要终点
- Rate of instrumental delivery
研究概览
简要总结
The study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia.
Moreover it will evaluate if automated devices can allow a reduction of health-care burden.
详细描述
Epidural analgesia is recognized as the most effective technique to control labor pain, although its possible adverse events. Continuous epidural administration of local anesthetics can stabilize the analgesic block and reduce the anesthesiologists' workload but is associated with an increase in operative vaginal delivery.
Epidural intermittent boluses performed by anesthetist are associated to reduction of dosages, but they could provide insufficient analgesia and they involve the constant anesthetist's presence in the operating room.
This is a multicenter randomized controlled trial with two arms, funded by grant of Regione Emilia Romagna, in which we will compare two different epidural analgesia protocols: anesthesiologist's supervised versus intermittent boluses with PCEA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm
- •Numeric Rate Scale > 5
排除标准
- •patients aged under 18 years
- •patients with ongoing administration of oxytocin
- •patients with no indications to epidural analgesia
- •patients with inability to place the epidural catheter for technical difficulty
- •patients with parenteral administration of opioids
- •multiparous women
- •patients unable to understand the objectives and procedures of the study
研究组 & 干预措施
Programmed Intermittent bolus (PIEB)
Intervention: epidural analgesia through administration of a mixture of levobupivacaine 0,0625% and sufentanil 4 mcg. Intermittent bolus of 10 ml mixture every 75 minutes. Patient controlled bolus of 5 ml same mixture, lock-out 15 minutes.
干预措施: Programmed Intermittent bolus (Device)
Programmed Intermittent bolus (PIEB)
Intervention: epidural analgesia through administration of a mixture of levobupivacaine 0,0625% and sufentanil 4 mcg. Intermittent bolus of 10 ml mixture every 75 minutes. Patient controlled bolus of 5 ml same mixture, lock-out 15 minutes.
干预措施: Levobupivacaine (Drug)
Programmed Intermittent bolus (PIEB)
Intervention: epidural analgesia through administration of a mixture of levobupivacaine 0,0625% and sufentanil 4 mcg. Intermittent bolus of 10 ml mixture every 75 minutes. Patient controlled bolus of 5 ml same mixture, lock-out 15 minutes.
干预措施: Sufentanil 4 mcg (Drug)
Manuale epidural bolus (TOP-UP)
Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
干预措施: Manual epidural bolus (Other)
Manuale epidural bolus (TOP-UP)
Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
干预措施: Levobupivacaine (Drug)
Manuale epidural bolus (TOP-UP)
Intervention: manual epidural bolus of 15 ml levobupivacaine 0,0625% and sufentanil 5 mcg on maternal request.
干预措施: Sufentanil 5 mcg (Drug)
结局指标
主要结局
Rate of instrumental delivery
时间窗: Through labor completion
Vaginal delivery obtained through vacuum device intervention decided independently by the obstetrician on duty, according to defined local protocols and according to the conditions of the mother and fetus.
次要结局
- Adequate analgesia(Labor length since peridural catheter insertion until delivery)
- Time-related amount of local anesthetic(Labor length since peridural catheter insertion until delivery)
- Motor block episodes(Labor length since peridural catheter insertion until delivery)
- Health economic assessment(Labor length since peridural catheter insertion until delivery)
- Anesthesiologist working time(Labor length since peridural catheter insertion until delivery)
- Total amount of local anesthetic(Labor length since peridural catheter insertion until delivery)
研究者
Laura Rinaldi
Medical Doctor
University of Modena and Reggio Emilia