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临床试验/NCT02362828
NCT02362828已完成不适用

EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics: European Prospective Multicentre Observational Audit to MAP Out Current Practices in the Management of Patients Who Had Accidental Dural Puncture During EPIdural Insertion

European Society of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 1,110 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,110
试验地点
1
主要终点
To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache

研究概览

简要总结

The aims of EPiMAP Obstetrics are:

  • to identify risk factors for failure of epidural blood patch in the obstetric population for management of post dural puncture headache.
  • to describe European practices in the management of accidental dural puncture in the Obstetric population.

详细描述

The primary aim of this prospective, international audit of practice is to identify risk factors for failure of epidural blood patch (EBP) in the Obstetric population after accidental dural puncture (ADP) with an epidural needle. Other aims are to describe the epidemiology, management principles, side effects and complications of ADP and longer-term effects of ADP on patients undergoing Obstetric anaesthesia and analgesia. Expectation is that this audit of practice will provide important information in understanding the reasons for failure of EBP and subsequently to better manage parturients affected by this debilitating complication.

Postdural puncture headache (PDPH) is the most common serious complication of accidental dural puncture (ADP), and feared by every Anaesthesiologist. It is associated with significant peri-partum maternal distress, and poor bonding with the baby, which in turn leads to physical disability for the mother and psychological and social implications for the whole family. It is estimated that about 10,000 parturients in Europe may have an accidental dural puncture (ADP) each year. Attitudes and practices in the management of ADP are based on small studies, and sometimes driven by experience rather than evidence. Although several methods have been described in the literature to treat PDPH, one common method used is an epidural blood patch (EBP). This is believed to be successful in about 60-80% of parturients on the first attempt, but results from most studies are based on a small numbers of patients. The reasons and predisposing factors for success and failure of different management strategies, specifically EBP, therefore needs to be investigated and described. Large observational studies on post-dural puncture headache in the Obstetric population are singularly absent from the literature.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •All women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section.

排除标准

  • •Post-dural puncture headache following deliberate dural puncture with a spinal needle in women where there was no observed accidental dural puncture with an epidural needle.

结局指标

主要结局

To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache

时间窗: 24 h after application of Epidural blood patch

To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache, in the obstetric population. Failure would be defined as lack of reduction in pain intensity by at least 50% at 24 h after application of EBP, compared to worst pain before EBP or a visual analogue pain score (VAS pain) of \> 3 at 24 h.

次要结局

  • Timing of the procedure (after diagnosis of PDPH) and the volume of blood injected in relation to success or failure(24 h after application of Epidural blood patch)
  • Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries(24 h after application of Epidural blood patch)
  • European practices in the management of Post Dural Puncture Headache (PDPH)(24 h after application of Epidural blood patch)
  • Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe(24 h after application of Epidural blood patch)
  • Complications and side effects of Epidural blood patch (EBP)(24 h after application of Epidural blood patch)

研究者

发起方
European Society of Anaesthesiology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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