BACKGROUND Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients' general activity and increases the length of hospital stays and the 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 for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective 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, for PDPH treatment in patients who receive neuraxial anaesthesia during labour. METHODS This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital 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 receiving 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 non-invasive alternative to blood patch for PDPH treatment. TRIAL REGISTRATION Primary Registry ClinicalTrials.gov Protocol Registration and Results System Date of Registration 24 June 2016 Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015-003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31 Protocol version V4 28/09/2018.

中文翻译：

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十四酸四硬脂酸酯治疗硬膜后穿刺性头痛（ESYBRECHE）的有效性和耐受性评估：一项随机对照试验的研究方案。

背景技术硬脑膜穿刺后头痛（PDPH）是神经麻醉的最常见并发症之一。它限制了患者的一般活动，并增加了住院时间和护理的使用时间。特别是在产后，母亲不得不照顾自己的孩子时，残疾尤为严重。硬膜外补血片是PDPH的标准治疗方法。但是，这是一种侵入性手术，可能导致罕见但严重的并发症。最近的证据表明，促肾上腺皮质激素（ACTH）在PDPH的治疗中有效。本研究的目的是评估ACTH的合成类似物四内酯（Synacthen®）在分娩期间接受神经麻醉的患者中进行PDPH治疗的有效性和安全性。方法这项随机，双盲，安慰剂对照，平行臂试验，在两家法国大学医院进行。合格的患者是产后PDPH的患者，他们被随机分配在20分钟内静脉内注射1 mg的十四酸或0.9％的生理盐水（安慰剂）。主要终点是在15天的随访期内硬膜外补血的比率。记录头痛持续时间，疼痛强度，一般活动的减少，住院时间的增加，不良事件，止痛药的使用（类型和持续时间）以及每组中每位患者的血斑数量。讨论我们预期接受四内酯治疗的患者使用硬膜外补血片的情况将减少，从而表明这些患者的PDPH症状有所减轻。这将定义四内酯的治疗成功以及将这种治疗用作PDPH治疗的血液修补剂的非侵入性替代方法的可能性。试用注册主注册ClinicalTrials.gov方案注册和结果系统注册日期2016年6月24日唯一方案ID 69HCL15_0429二级ID EudraCT号2015-003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31协议版本V4 28/09/2018。