Topical Formulations of Liposomal Local Anesthetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Administration, Topical Drug Administration, Topical Anesthetic Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Liposomal ropivacaine, topical

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

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

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.

Liposomal ropivacaine, palatal mucosa

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.

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

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.

Interventions

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Ropivacaine

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.

Intervention Type DRUG

Ropivacaine

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.

Intervention Type DRUG

Other Intervention Names

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Topical anesthesia in the palatal mucosa Topical anesthesia in the buccal mucosa.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes