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

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    88
  • sponsor
    Hospices Civils de Lyon
Updated on 25 February 2022
analgesia
nausea
migraine
headache
photophobia
neck stiffness
eclampsia

Summary

The aim of the study is to assess the efficacy and safety of Synacthne versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.

Details
Condition Post-dural Puncture Headache
Treatment Tetracosactide (Synacthène®), placebo saline (0.9% NaCl)
Clinical Study IdentifierNCT02813655
SponsorHospices Civils de Lyon
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All women who received epidural, spinal, or combined spinal-epidural labour
analgesia and presenting post-dural puncture headache
Intense: with 3 / 10 numerical rating pain scale
Appearing within 5 days after delivery
Aggravating in sitting or standing position and / or improving supine
Can be associated with one of the following criteria: tinnitus, nausea, photophobia, neck stiffness or pain, hearing loss
After exclusion of clinically differential diagnoses (preeclampsia or eclampsia, cerebral venous thrombosis, migraine)
Age greater than or equal to 18 years
Affiliation to social security scheme
Inform Consent signed after oral and written information

Exclusion Criteria

Presence of diplopia (indication of immediate blood patch)
Contraindication to ACTH or Synacthne (unbalanced hypertension, uncontrolled diabetes, uncontrolled psychosis, infectious viral disease state or evolving)
Processing of Torsade de Pointe provider (astenizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)
Live vaccine in the months prior to inclusion
Hypersensitivity to Synacthne
Patient who have previously received Synacthne after delivery
Contraindication to blood patch (fever or leukocytosis, HIV or HCV patient)
Eclampsia or preeclampsia during this pregnancy
Patient who have received prophylactic blood patch (at diagnosis of Accidental Dural Puncture)
Minor under 18 or protected
Psychological disorders do not allowing informed consent
Refusal of participation in the study or participation in another ongoing interventional study
Withdrawal of consent
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