Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospices Civils de Lyon
Treatments:
Cosyntropin
Criteria
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 Synacthène® (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 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 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