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

NCT01303107 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-03-26

No results posted yet for this study

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).

Conditions

  • Cesarean Delivery

Interventions

DRUG

Bupivacaine

single dose of 15 mg by a slow injection rate of 1 mL/s

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • Irmandade da Santa Casa da Misericórdia de Santos

    collaborator UNKNOWN

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Principal Investigators

  • Liga Mathias, PhD · Irmandade da Santa Casa de Misericórdia de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303107 on ClinicalTrials.gov