Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean

A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation

The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).

The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).

Inclusion Criteria:

• parturients at term
• ASA (American Society of Anesthesiologists) I or ASA II
• elective cesarean section with low risk labor
• pre-natal follow-up
• patient consent

Exclusion Criteria:

• relative or absolute contraindications for spinal anesthesia
• history of hypersensitivity to the local anesthetics
• use of opioids during labor
• labor lasting more than 12 hours or less than 1 hour
• complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy.
• spinal lesions, peripheral neuropathies or any other neurologic disorders that lead to changes of sensitivity and/or motricity
• decompensated diabetes or hypertension
• history of alcohol and/or drug abuse
• cardiopathies, especially myocardiopathies and valvulopathies; important cognitive changes
• changes in safety exams
• twin pregnancy;
• signs of intrauterine distress, and abnormalities of fetal vitality, prematurity