Formulations of Liposomal Local Anesthetics

Phase 1

Completed

• Conditions: Underdosing of Local Anesthetics, Initial Encounter
• Interventions: Drug: Ropivacaine

• Registration Number: NCT01307969
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Status Verified: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-03-02
• Last Update Submitted: 2011-03-02
• Study First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Arm && Interventions

Group	Intervention	Description
Anesthetic efficacy	Ropivacaine	Local anesthetics were injected at the apex of the maxillary right canine.

Primary Outcome Measures

Name	Time	Method
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.	100 minutes

Secondary Outcome Measures

Name	Time	Method
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.	240 minutes

Trial Locations

Locations (1)

Piracicaba Dental School; 🇧🇷 Piracicaba, São Paulo, Brazil