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临床试验/NCT02768272
NCT02768272已完成4 期

A Randomized Double Blind Clinical Trial Comparing Programed Intermittent Epidural Boluses (PIEB) Versus Patient Controlled Epidural Analgesia (PCEA) With Epidural or Combined Spinal-epidural (CSE) Technique

Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
240
试验地点
1
主要终点
Incidence of breakthrough pain

研究概览

简要总结

The investigators have design a randomized double blind clinical trial to know the incidence of breaktrough pain (BP) in high-risk of BP parturients (nulliparous with early cervical dilation) comparing two epidural analgesic regimes: programed intermittent epidural boluses versus patient controlled epidural analgesia. The role of the epidural technique (epidural versus combined spinal-epidural) in the incidence of BP will be also evaluated.

详细描述

Women in labor receiving epidural analgesia may experience breakthrough pain (BP) that requires the use of additional medication and that is a source of dissatisfaction with the analgesic treatment for labor.

The investigators can define two types of BP: 'primary breakthrough pain' is the first moment when the patient requests analgesia during labor. 'Secondary breakthrough pain' can be defined as the time a previously effective epidural analgesia turns ineffective.

The BP may have multiple causes, such as delivery progression and catheter misplacement. There is no single pattern to provide adequate neuraxial analgesia for labor, but for certain patients and specific clinical situations some methods provide advantages over others.

The choice of a suitable system of epidural drug delivery has an important role in getting proper analgesia and a low incidence of breakthrough pain during labor. In order to develop preventive strategies for BP, some clinical scales to estimate its incidence rate have been described. Among risk factors for BP the investigators can include: Nulliparity, epidural catheter placement at an earlier cervical dilation, neonatal weight and technique performed (epidural versus combined spinal-epidural - CSE).

In addition, technological development has offered us new treatment modalities of pain management during childbirth have evolved recently to improve maternal satisfaction, as well as to treat and prevent BP: Patient Controlled Epidural Analgesia (PCEA) added or not to a continuous epidural infusion (CEI), computer integrated PCEA (CI-PCEA) and automatic or programed intermittent epidural boluses (PIEB).

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age between 18 and 40 years
  • •Gestational age between 37 and 41 weeks
  • •Singleton pregnancies
  • •Nulliparity
  • •Spontaneous or induced labor
  • •Cervical dilation less than four centimeters

排除标准

  • •Do not meet all the inclusion criteria
  • •Do not consent to the study
  • •Systemic medical pathologies as pre-eclampsia, insulin-treated gestational diabetes or multiple sclerosis that could influence medical decision during labour and/or make randomization unfeasible
  • •Contraindication for neuraxial analgesia

研究组 & 干预措施

Epidural analgesia

Experimental

Randomized allocation to receive patient controlled epidural analgesia or programed intermittent epidural boluses

干预措施: PCEA vs PIEB (Device)

Epidural technique

Experimental

Randomized allocation to be punctioned a conventional epidural or a combined spinal-epidural technique

干预措施: Epidural vs CSE (Procedure)

结局指标

主要结局

Incidence of breakthrough pain

时间窗: Labor

Evaluation of breakthough pain episodes since epidural punction to delivery

次要结局

  • Mode of delivery (spontaneous, intrumental and cesarean section)(Delivery)
  • Total epidural infusion volume(Labor)
  • Incidence of epidural failure(Labor)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emilia Guasch

Head of the Anesthesia and Intensive Care Department

Hospital Universitario La Paz

研究点 (1)

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