Formulations of Liposomal Local Anesthetics

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: February 16, 2011
Last updated: March 2, 2011
Last verified: February 2011
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Condition Intervention Phase
Underdosing of Local Anesthetics, Initial Encounter
Drug: Ropivacaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • After anesthetic injection the pulpal response was assessed by an electrical pulp tester. [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness. [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anesthetic efficacy
Local anesthetics were injected at the apex of the maxillary right canine.
Drug: Ropivacaine
1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
Other Names:
  • 0,5% ropivacaine encapsulated in liposomes
  • 0,5% ropivacaine with epinephrine 1:200.000
  • 2% lidocaine with epinephrine 1:100.000

Detailed Description:
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01307969

Piracicaba Dental School
Piracicaba, São Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Michelle Franz-Montan, PhD Researcher at Unicamp
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michelle Franz-Montan, Unicamp Identifier: NCT01307969     History of Changes
Other Study ID Numbers: 164/2006 
Study First Received: February 16, 2011
Last Updated: March 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
dental anesthesia

Additional relevant MeSH terms:
Anesthetics, Local
Epinephryl borate
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on May 05, 2016