drugset / Trial / NCT02813655
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-10
- Primary completion
- 2022-11
- Completion
- 2022-11-21
Outcome
Missed primary endpoint
Stopped: “Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)”
paper no significant difference was found for the primary outcome PMID 40393818 ↗
paper A single dose of tetracosactide did not demonstrate efficacy in preventing EBP needs in postpartum PDPH PMID 40393818 ↗
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tetracosactide | Unknown | 1 mg | Intravenous |