Comparison of Levobupivacaine and Ropivacaine for epidural application in obstetric gynaecology
Conditions
Interventions
Trade Name: Chirocain 5 mg/ml
Product Name: Levobupivacainhydrochlorid
Product Code: 58910.01.00
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Chirocain
CAS Number:
Sponsors
Klinikum Leverkusen gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It is the primary aim to show the safety and efficiancy of levobupivacaine when compared to ropivacain as well as patient and user satisfaction in obstetric gynaecology. Under conditions of clinical obstetric gynaecology, the equal use of levobupivacaine and ropivacaine, both approved by the German bord for drug safety, without risk for pregnant women as well as the newborn. ;Secondary Objective: Cardiovascular Parameters (Blood pressure, Heart rate) Patient satisfaction with the medication User satisfaction with the medication Surgeons satisfaction with the medication for caesarean Documentation of Lack of toxic side effects Documentation of analgesic potency Dokumentation of side effects and adverse events Documentation of additionally needed medication Usability of the medication ;Primary end point(s): It is the primary aim to show the safety and efficiancy of levobupivacaine when compared to ropivacain as well as patient and user satisfaction in obstetric gynaecology. Under conditions of clinical obstetric gynaecology, the equal use of levobupivacaine and ropivacaine, both approved by the German bord for drug safety, without risk for pregnant women as well as the newborn Decrease of blood pressure will be different between groups, (levobupivacain vs. ropivacain) assuming that a higher concentration causes a greater decrease: If the difference of decrease in blood pressure is assumend to be 20% for the group of patients giving spontaneous birth the number of patients required will be 72 for each group. Under the assumption that the diffrence will be 25% under ceasarean, the number of patients need will be 43 in each group. | — |
Countries
Germany
Outcome results
None listed