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

What Was Tested

This clinical study looks at Cosyntropin.

Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia.

It is particularly disabling during the postpartum period, when mothers have to take care of their child.

Who Took Part

PubMed indexes the participants as young adults and adults, women only.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

The participants were allocated by chance, so the Cosyntropin group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Cosyntropin, so expectations could not easily colour the readings.

Some participants received a placebo instead of Cosyntropin, giving a reference point.

The Cosyntropin group and the comparison group ran side by side rather than switching.

This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals.

What Was Measured

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.

PubMed files the paper under topics including Administration, Intravenous, Analgesics, Anesthesia, Epidural, Anesthesia, Obstetrical, Blood Patch, Epidural, Clinical Trials, Phase II as Topic and Cosyntropin.

The authors tagged it with the keywords Blood-patch, Post-dural puncture headache, Postpartum and Tetracosactide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cosyntropin.

Its findings take up roughly 2 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2020 (Trials), a journal based in England.

More context: the Cosyntropin compound page, all human trials.