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

Civil Hospices of Lyon

Status and phase: Terminated; Phase 2

Conditions: Post-dural Puncture Headache

Treatments: Drug: Tetracosactide (Synacthène®); Drug: placebo saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT02813655

69HCL15_0429

2015-003357-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

Description:

Tetracosactide (Synacthène®)

Treatment:

Drug: Tetracosactide (Synacthène®)

Control arm

Placebo Comparator group

Description:

placebo saline (0.9% NaCl)

Treatment:

Drug: placebo saline (0.9% NaCl)