Formulations of Liposomal Local Anesthetics

Underdosing of Local Anesthetics, Initial Encounter Clinical Trial

Official title:

Formulations of Liposomal Local Anesthetics for Dental Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307969
• Other study ID #: 164/2006
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2011
• Last updated: March 2, 2011
• Start date: February 2007
• Est. completion date: June 2007

Study information

• Verified date: February 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Underdosing of Local Anesthetics, Initial Encounter

Intervention

Drug:
• Ropivacaine
1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After anesthetic injection the pulpal response was assessed by an electrical pulp tester.		100 minutes	No
Secondary	Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.		240 minutes	No