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Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.

NCT01994967 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-21

No results posted yet for this study

Summary

Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.

Conditions

  • Orthopedic Disorder of Spine

Interventions

DRUG

Levobupivacaine

Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.

DRUG

Bupivacaine

Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.

Sponsors & Collaborators

  • Newco Trials Pesquisa Científica Ltda

    collaborator INDUSTRY

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    lead INDUSTRY

Principal Investigators

  • Onésimo D. Ribeiro Junior, Medic · CEMEC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-12-31
Completion
2017-01-31

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 NCT01994967 on ClinicalTrials.gov