Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

Abstract

Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anesthesia. It limits patients’ general activity and increases hospital length of stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment of PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence suggests the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, in the treatment of PDPH in patients who received neuraxial anesthesia during labor. Method This is a randomized, double-blinded, placebo-controlled, parallel-arm trial, performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomized to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. Duration of headache, intensity of pain, reduction of general activity, increase of hospital length of stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a noninvasive alternative to blood patch in the treatment of PDPH.