EUCTR2004-005060-24-DE进行中（未招募）不适用
Comparison of Levobupivacaine and Ropivacainefor epidural application in obstetric gynaecology
Klinikum Leverkusen gGmbH0 个研究点开始时间: 2005年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •All pregnant women (ASA I – III) at the date of birth (= 36 Week or = 41 SSW), = 18 years, who give written consent (see information and consent) to take part in the trial and do not fullfill one ore more criteria for exclusion as listed below.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Refusion of partizipation in the trial
- •Participation in another trial at the same time
- •General contraindications for regional anesthesia
- •Start of th trial between 22.00 Hours and 7.45 hours in the morning
- •Allergic disposition for localanaesthetics of the amide type
- •Eclampsis or preeclampsis
- •HELLP Syndrom
- •History of problems with blood coagulation or medication that inhibits normal blood coagulation. Guidelines of the German Association of Anaesthesiology and intensive Care medicine (DGAI) will be applied (5).
- •Medication with hypnotic effect or sedation up to 12 hours prior epidural analgesia
- •Regular medication with pain reliefing drugs
- •Drug and/or alcohol abuse within the last 12 months
- •Cardiovascular disease of the pregnant woman:
- •Treated or untreated heart insufficiency
- •Arrythmia, treatment with medication needed
- •Valvular defect
- •Septum defect
- •Endo- or myocarditis within the last 12 months
- •Cardiac medication in particular with antiarrhythmics class III or mexiletin myocardial infarcation or angina greater CCS II in medical history
- •Cerebrovascular diseases such as transitoric ischemic attack (TIA) or apoplexia in medical history
- •Heart attack verified by ECG (new Q waves or ST Elevation), constellation of laboratory parameters (myocardial creatinkinase greater 70 ng/ml or greater 5% of total creatinicinase, Troponin >2) up to 12 hours before epidural catheter.
- •Treated or untreated epilepsy
- •Prenatal diagnosis of fetal disformities
- •Small for date babies below 1500 gr at date of birth
- •Cognitive impairment of the patient that may cause wrong results or lack of compliance with the trial
- •Chronic disease that might have influence on the results or worsen under the distress of labour and birth
- •Previous participation in the study
研究者
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