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Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.

NCT01308047 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL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 compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

Conditions

  • Fracture of Lower Limb

Interventions

DRUG

Bupivacaine

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

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo

    collaborator UNKNOWN

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Principal Investigators

  • Ligia 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
80 Years
Sex
ALL
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 NCT01308047 on ClinicalTrials.gov