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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: Irmandade da Santa Casa da Misericórdia de Santos; Irmandade da Santa Casa de Misericordia de Sao Paulo
• Treatments: Bupivacaine

Criteria

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