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Published in: Trials 1/2020

Open Access 01-12-2020 | Headache | Study protocol

Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial

Authors: Célia Depaulis, Nadia Steer, Léa Garessus, Dominique Chassard, Frédéric Aubrun

Published in: Trials | Issue 1/2020

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Abstract

Background

Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour.

Methods

This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded.

Discussion

We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment.

Trial registration

Primary Registry
ClinicalTrials.gov Protocol Registration and Results System
Date of Registration 24 June 2016
Unique Protocol ID 69HCL15_0429
Secondary IDs
EudraCT Number 2015–003357-17
ClinicalTrials.gov ID NCT02813655
ANSM 160214A-31
Protocol version
V4 28/09/2018
Appendix
Available only for authorised users
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Metadata
Title
Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial
Authors
Célia Depaulis
Nadia Steer
Léa Garessus
Dominique Chassard
Frédéric Aubrun
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Headache
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-4015-y

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