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

Cesarean Delivery Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01303107
Study type Interventional
Source Cristália Produtos Químicos Farmacêuticos Ltda.
Contact
Status Withdrawn
Phase Phase 3
View Details
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