No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial.

BACKGROUND Postdural puncture headache (PDPH) is a common complication of neuraxial anaesthesia in obstetrics. Although epidural blood patch (EBP) remains the most effective treatment, less invasive alternatives are being explored. We assessed the efficacy and safety of tetracosactide, a synthetic adrenocorticotropic hormone analogue, for treating established PDPH in postpartum patients. METHODS A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals. Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo. The primary outcome was the rate of EBP within the 15-day follow-up. Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient. Interim analysis to determine futility and trial termination was planned at 50% enrolment. RESULTS At interim analysis with 44 patients enrolled (23 in the treatment group and 21 in the placebo group) no significant difference was found for the primary outcome: 21 (91%) patients in the treatment group and 18 (86%) patients in the placebo group received EBP (P=0.6575). Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486). The study was terminated because of futility. No side-effects of tetracosactide administration were observed. CONCLUSIONS A single dose of tetracosactide did not demonstrate efficacy in preventing EBP needs in postpartum PDPH, and there was no effect on the intensity, duration of headaches, and physical activity limitations. Given these findings, adrenocorticotropic hormone analogues should not be considered for this indication. CLINICAL TRIAL REGISTRATION European Union Clinical Trials Register (2015-003357-17); ClinicalTrials.gov (NCT02813655); French Agence Nationale de Sécurité du Médicament et des Produits de Santé (160214A-31).