A comparison of chloroprocaine 3% versus levobupivacaine 0.5% for epidural anesthesia during caesarean section.
Phase 1
- Conditions
- anesthetics for women scheduled for elective caesarean sectionTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-004918-22-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Pregnant patients scheduled for elective caesarean section
•=37 weeks of pregnancy
•ASA1
•Between 18 and 40 years old
•Able to comprehend, sign and date the written informed consent document to participate in the clinical trial
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Pregnancy < 37 w
•Pre-eclampsia
•Height < 152 cm
•Weight>115 kg
•ASA = 2
•Neurologic disorder
•Fetal abnormalities
•Twin (or more) pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary hypothesis of this study is that the onset of action for chloroprocaine is more rapid than the onset time for levobupivacaine in elective caesarean section;Secondary Objective: Secondary hypothesis is that the duration of action is less for chloroprocaine vs levobupivacaine.;Primary end point(s): onset time;Timepoint(s) of evaluation of this end point: 0, 2, 5, 10 15, 20, 25 and 30 min
- Secondary Outcome Measures
Name Time Method Secondary end point(s): duration of response;Timepoint(s) of evaluation of this end point: 2, 4 and 24h after surgery