Topical Formulations of Liposomal Local Anesthetics

University of Campinas, Brazil80 enrolled

Overview

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Administration, Topical Drug Administration, Topical Anesthetic Drugs

Interventions

RopivacaineDRUG

100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.

RopivacaineDRUG

100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Piracicaba Dental School

Piracicaba, São Paulo, Brazil

Outcomes

Primary Outcomes

After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.

Time frame: 10 minutes

Secondary Outcomes

The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).

Time frame: 10 seconds after removal of topical formulation

Data from ClinicalTrials.gov

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