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

Phase 2

Terminated

• Conditions: Post-dural Puncture Headache
• Interventions: Drug: Tetracosactide (Synacthène®); Drug: placebo saline (0.9% NaCl)

• Registration Number: NCT02813655
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-27
• Study Start: 2016-10
• Primary Completion: 2022-11
• Study Completion: 2022-11-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Tetracosactide (Synacthène®)	Tetracosactide (Synacthène®)
Control arm	placebo saline (0.9% NaCl)	placebo saline (0.9% NaCl)

Primary Outcome Measures

Name	Time	Method
Rate of blood patch use	Day 15	Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospices Civils de Lyon - Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Hospices Civils de Lyon / hôpital de la Croix rousse; 🇫🇷 Lyon, France