Local Anesthetics New Formulations: From Development to Clinical Tests

Phase 1

Completed

• Conditions: Local Anesthetic Effectiveness

• Registration Number: NCT01032798
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-04
• Study Start: 2007-05
• Study Completion: 2008-05
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Submitted: 2010-01-19
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy

Exclusion Criteria

• Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Latency period and duration of anesthesia were assessed by an electrical pulp tester	10 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of mepivacaine	0 to 360 minutes after the injection

Trial Locations

Locations (1)

University of Campinas; 🇧🇷 Campinas, Sao Paulo, Brazil