Comparative doubleblind study with prilocaine 2 % and 2-chloroprocaine for elective caesarean section.
- Conditions
- Healthy pregnant women undergoing a elective caesarean section with an uncomplicated pregnancy of a singleton, full-term, all between 18-40 y (ASAI-II) through combined spinal and epidural approach.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-000813-63-BE
- Lead Sponsor
- niversitair Ziekenhuis Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 80
•Gender: female
•18-40 years
•American Society of Anesthesiologists physical status I - II
Indication for elective caesarean section of uncomplicated singleton pregnancy at term (37 weeks or more)
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
•Women who belong to ASA III-IV classification
•BMI > 35
•length < 150 cm
•foetus with known fetal abnormality
•pregnancy less than 37 weeks
•(pre) eclampsia
•Ever had an allergic reaction to a local anesthetic in the past
•Signs of skin infection or inflammation at or near the proposed site of the injection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The goal of this trial is to investigate the efficacy of the IMP during caesarean section with and without the use of Sufenta: as well as onset of action and duration of action, the degree of motor block and level of sensory block will be investigated.;Secondary Objective: The secondary objectives are to evualate (dis)comfort (pain scores by Visual Analog Scale 0-10) of the patient (especially during externalisation and internalisation of the uterus), hemodynamics perioperative and possible side effects.;Primary end point(s): Superiority of Tachipri in clinical use for elective caesarean section;Timepoint(s) of evaluation of this end point: Perioperative
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -VAS scores<br>- Hemodynamics<br>- Side effects;Timepoint(s) of evaluation of this end point: Perioperative