NCT02813655

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-11-01
• Completion: 2022-11-21
• First posted: 2016-06-27
• Last updated: 2025-08-08

Locations

2 sites across 1 country: France