Clinical trial NCT02813655: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Official title: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post-dural Puncture Headache
Keywords: tetracosactide
Synacthène®
cosyntropin
post-dural syndrom
post-dural puncture headache
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Rate of blood patch use
timeFrame: Day 15
Secondary outcomes:
measure: Side effects
timeFrame: Day 15
measure: Duration of headache
timeFrame: Day 15
measure: Intensity of headache
timeFrame: Day 15
measure: analgesic use (type and duration) in each group (control and experimental)
timeFrame: Day 15
measure: blood-patch number
timeFrame: Day 15
measure: Time to first analgesic use after injection of treatment (Synacthène® or placebo)
timeFrame: Day 15
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Hospices Civils de Lyon / hôpital de la Croix rousse
Study officials:
References:
citation: Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.