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

NCT02813655 | Terminated Phase 2 DMC

• 2 other identifiers: 69HCL15_04292015-003357-17
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-dural Puncture Headache

Keywords

tetracosactide; Synacthène®; cosyntropin; post-dural syndrom; post-dural puncture headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Side effects

  Day 15

• Duration of headache

  Day 15

• Intensity of headache

  Day 15

• analgesic use (type and duration) in each group (control and experimental)

  Day 15

• blood-patch number

  Day 15

Study Arms (2)

Experimental arm

EXPERIMENTAL

Tetracosactide (Synacthène®)

Drug: Tetracosactide (Synacthène®)

Control arm

PLACEBO COMPARATOR

placebo saline (0.9% NaCl)

Drug: placebo saline (0.9% NaCl)

Interventions

Tetracosactide (Synacthène®) DRUG

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.

Experimental arm

placebo saline (0.9% NaCl) DRUG

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age greater than or equal to 18 years
• Affiliation to social security scheme
• Inform Consent signed after oral and written information

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, France

Location

Hospices Civils de Lyon / hôpital de la Croix rousse

Lyon, 69004, France

Location

Related Publications (2)

• Dziadzko M, Bouvet L, Steer N, Depaulis C, Pradat P, Joubert F, Lalande L, Chassard D, Aubrun F. No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial. Br J Anaesth. 2025 Jul;135(1):148-154. doi: 10.1016/j.bja.2025.04.012. Epub 2025 May 19.

  PMID: 40393818 RESULT

• 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.

  PMID: 31915040 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Cosyntropin

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 27, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 21, 2022
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (2)