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

Last updated: August 5, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Terminated

Phase

2

Condition

Chronic Pain

Pain

Pain (Pediatric)

Treatment

placebo saline (0.9% NaCl)

Tetracosactide (Synacthène®)

Clinical Study ID

NCT02813655
69HCL15_0429
2015-003357-17
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Presence of diplopia (indication of immediate blood patch)

  • Contraindication to ACTH or Synacthène® (unbalanced hypertension, uncontrolleddiabetes, 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 Synacthène®

  • Patient who have previously received Synacthène® 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 DuralPuncture)

  • Minor under 18 or protected

  • Psychological disorders do not allowing informed consent

  • Refusal of participation in the study or participation in another ongoinginterventional study

  • Withdrawal of consent

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: placebo saline (0.9% NaCl)
Phase: 2
Study Start date:
October 01, 2016
Estimated Completion Date:
November 21, 2022

Connect with a study center

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron,
    France

    Site Not Available

  • Hospices Civils de Lyon / hôpital de la Croix rousse

    Lyon, 69004
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.