Topical Formulations of Liposomal Local Anesthetics

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Administration, Topical Drug; Anesthetic Drugs; Administration, Topical

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01054547

093/2006

Details and patient eligibility

About

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

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Liposomal ropivacaine, topical

Placebo Comparator group

Description:

The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.

Treatment:

Drug: Ropivacaine

Drug: Ropivacaine

Liposomal ropivacaine, palatal mucosa

Placebo Comparator group

Description:

Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.

Treatment:

Drug: Ropivacaine

Drug: Ropivacaine