Evidence map›Paper›PMID 31915040›Full record

ArticleTrials2020

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.

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02813655 (Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02813655 phase2terminatednot on this map

Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

TypeinterventionalSponsorHospices Civils de LyonRan2016 to 2022Enrolled46ConditionsPost-dural Puncture HeadacheArmsTetracosactide (Synacthène®), placebo saline (0.9% NaCl)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Célia DepaulisHospices Civils de Lyon, Hôpital Femme Mère Enfant, Lyon, France. celia.depaulis@gmail.com.ORCID http://orcid.org/0000-0002-4164-0202
Nadia SteerHospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.
Léa GaressusHospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.
Dominique ChassardHospices Civils de Lyon, Hôpital Femme Mère Enfant, Lyon, France.
Frédéric AubrunHospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.
Hôpital de la Croix-Rousse · FRHôpital Femme Mère Enfant · FRUniversité Claude Bernard Lyon 1 · FR

Funding

fondation Apicil INTA0400082DFondation de France fr/784314908
6 · The paper itself

Abstract

backgroundPost-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.

methodsThis 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 registrationPrimary 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.

Indexed as

Administration, IntravenousAdultAnalgesicsAnesthesia, EpiduralAnesthesia, ObstetricalBlood Patch, EpiduralClinical Trials, Phase II as TopicCosyntropinDouble-Blind MethodFemaleHormonesHumansLength of StayPain ManagementPain MeasurementPost-Dural Puncture HeadacheAnalgesicsCosyntropinHormonesBlood-patchCosyntropinEpiduralPost-dural puncture headachePostpartumTetracosactide

Identifiers

PMID31915040
PMCPMC6950989
OpenAlexW3004814333

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.