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

Post-Dural Puncture Headache Clinical Trial

— EPiMAP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362828
• Other study ID #: EPiMAP Obstetrics
• Status: Completed
• Start date: January 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2018
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1110
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Wounds and Injuries

Locations

Country	Name	City	State
Sweden	Karolinska Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Gupta A, von Heymann C, Magnuson A, Alahuhta S, Fernando R, Van de Velde M, Mercier FJ, Schyns-van den Berg AMJV; EPiMAP collaborators. Management practices for postdural puncture headache in obstetrics: a prospective, international, cohort study. Br J An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache	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.	24 h after application of Epidural blood patch
Secondary	European practices in the management of Post Dural Puncture Headache (PDPH)		24 h after application of Epidural blood patch
Secondary	Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe		24 h after application of Epidural blood patch
Secondary	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
Secondary	Complications and side effects of Epidural blood patch (EBP)	Complications include : Chronic headache and backache, neurological injuries, audiological or visual other chronic impairments	24 h after application of Epidural blood patch
Secondary	Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries		24 h after application of Epidural blood patch

External Links

•   EPiMAP Obstetrics section of the ESAIC website