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

August 5, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
      • Lyon, France, 69004
        • Hospices Civils de Lyon / Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Tetracosactide (Synacthène®)
Drug: Tetracosactide (Synacthène®)

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.
Placebo Comparator: Control arm
placebo saline (0.9% NaCl)
Drug: placebo saline (0.9% NaCl)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of blood patch use
Time Frame: Day 15
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
Time Frame: Day 15
Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15
Day 15
Duration of headache
Time Frame: Day 15
Duration of headache in each group (control and experimental) between day 0 and day 15
Day 15
Intensity of headache
Time Frame: Day 15
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)
Time Frame: Day 15
analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15
Day 15
blood-patch number
Time Frame: Day 15
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)
Time Frame: Day 15
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimated)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0429
  • 2015-003357-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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