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Completed

NCT Number: NCT02362828

EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. European practices in the management of Post Dural Puncture Headache (PDPH)

    Time frame: 24 h after application of Epidural blood patch

  2. Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe

    Time frame: 24 h after application of Epidural blood patch

  3. Timing of the procedure (after diagnosis of PDPH) and the volume of blood injected in relation to success or failure

    Time frame: 24 h after application of Epidural blood patch

  4. Complications and side effects of Epidural blood patch (EBP)

    Time frame: 24 h after application of Epidural blood patch

    Complications include : Chronic headache and backache, neurological injuries, audiological or visual other chronic impairments

  5. Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries

    Time frame: 24 h after application of Epidural blood patch

Sponsors and collaborators

Lead sponsor

European Society of Anaesthesiology

Other

Registry information

Official study title

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

Acronym: EPiMAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 13, 2015
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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