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Local Anesthetics New Formulations: From Development to Clinical Tests

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil Identifier:
First received: December 15, 2009
Last updated: January 19, 2010
Last verified: April 2007
This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Condition Intervention Phase
Local Anesthetic Effectiveness Drug: mepivacaine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry

Resource links provided by NLM:

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Latency period and duration of anesthesia were assessed by an electrical pulp tester [ Time Frame: 10 minutes ]

Secondary Outcome Measures:
  • Plasma concentrations of mepivacaine [ Time Frame: 0 to 360 minutes after the injection ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: May 2008
Intervention Details:
    Drug: mepivacaine
    One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01032798

University of Campinas
Campinas, Sao Paulo, Brazil, 13083-970
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Director: Eneida de Paula, PHD University of Campinas, Brazil
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Giovana R. Tofoli, UNICAMP Identifier: NCT01032798     History of Changes
Other Study ID Numbers: 06/00121-9
Study First Received: December 15, 2009
Last Updated: January 19, 2010

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on June 23, 2017