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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-dural Puncture Headache

Intervention / Treatment
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* Drug: Tetracosactide (Synacthène®)
* Drug: placebo saline (0.9% NaCl)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Tetracosactide (Synacthène®) | Drug: Tetracosactide (Synacthène®)<br>* Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.<br>|
| Placebo Comparator: Control arm<br>placebo saline (0.9% NaCl) | Drug: placebo saline (0.9% NaCl)<br>* placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of blood patch use | Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15. | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15 | Day 15 | 
| Duration of headache | Duration of headache in each group (control and experimental) between day 0 and day 15 | Day 15 | 
| Intensity of headache | Intensity of headache in each group (control and experimental) between day 0 and day 15 | Day 15 | 
| analgesic use (type and duration) in each group (control and experimental) | analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15 | Day 15 | 
| blood-patch number | blood-patch number per patient in each group (control and experimental) between day 0 and day 15 | Day 15 | 
| Time to first analgesic use after injection of treatment (Synacthène® or placebo) |  | Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tetracosactide, Synacthène®, cosyntropin, post-dural syndrom, post-dural puncture headache