NCT02813655终止2 期
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Rate of blood patch use
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women who received epidural, spinal, or combined spinal-epidural labour analgesia and presenting post-dural puncture headache:
- •Intense: with ≥3 / 10 numerical rating pain scale
- •Appearing within 5 days after delivery
- •Aggravating in sitting or standing position and / or improving supine
- •Can be associated with one of the following criteria: tinnitus, nausea, photophobia, neck stiffness or pain, hearing loss
- •After exclusion of clinically differential diagnoses (preeclampsia or eclampsia, cerebral venous thrombosis, migraine)
- •Age greater than or equal to 18 years
- •Affiliation to social security scheme
- •Inform Consent signed after oral and written information
排除标准
- •Presence of diplopia (indication of immediate blood patch)
- •Contraindication to ACTH or Synacthène® (unbalanced hypertension, uncontrolled diabetes, uncontrolled psychosis, infectious viral disease state or evolving)
- •Processing of Torsade de Pointe provider (astenizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)
- •Live vaccine in the months prior to inclusion
- •Hypersensitivity to Synacthène®
- •Patient who have previously received Synacthène® after delivery
- •Contraindication to blood patch (fever or leukocytosis, HIV or HCV patient)
- •Eclampsia or preeclampsia during this pregnancy
- •Patient who have received prophylactic blood patch (at diagnosis of Accidental Dural Puncture)
- •Minor under 18 or protected
- •Psychological disorders do not allowing informed consent
- •Refusal of participation in the study or participation in another ongoing interventional study
- •Withdrawal of consent
研究组 & 干预措施
Experimental arm
Experimental
Tetracosactide (Synacthène®)
干预措施: Tetracosactide (Synacthène®) (Drug)
Control arm
Placebo Comparator
placebo saline (0.9% NaCl)
干预措施: placebo saline (0.9% NaCl) (Drug)
结局指标
主要结局
Rate of blood patch use
时间窗: Day 15
Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15.
次要结局
- analgesic use (type and duration) in each group (control and experimental)(Day 15)
- blood-patch number(Day 15)
- Time to first analgesic use after injection of treatment (Synacthène® or placebo)(Day 15)
- Duration of headache(Day 15)
- Side effects(Day 15)
- Intensity of headache(Day 15)
研究者
研究点 (2)
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