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