Randomised comparative trial of Bupivacaine and 2-Chloroprocaine by caesarean section.
- Conditions
- Healthy pregnant women undergoing a planned c-section with an uncomplicated pregnancy of a singleton, full-term, all between the age of 18-40 y (ASAI-II).Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002815-88-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
All healthy(ASA I-II) women with an uncomplicated singleton pregnancy between 18-40 y undergoing a planned caesarian. Pregnancy > or equal to 37 weeks.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Women who belong to ASA III-IV classification, BMI >35, length <150 cm, foetus with known fetal abnormality, pregnancy less than 37 weeks, known allergy for the used local anesthetics and (pre) eclampsia.
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