Comparison of Levobupivacaine and Ropivacainefor epidural application in obstetric gynaecology
- Conditions
- Comparison of Levobupivacaine and Ropivacainefor epidural application in obstetric gynaecology
- Registration Number
- EUCTR2004-005060-24-DE
- Lead Sponsor
- Klinikum Leverkusen gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
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
ASA IV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method