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

Cristalia

Status and phase

Withdrawn

Phase 3

Conditions

Cesarean Delivery

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01303107

CRIST019

Details and patient eligibility

About

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).

Full description

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).

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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