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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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

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Detailed Description

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

Conditions

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Underdosing of Local Anesthetics, Initial Encounter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Anesthetic efficacy

Local anesthetics were injected at the apex of the maxillary right canine.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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

Interventions

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Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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0,5% ropivacaine encapsulated in liposomes 0,5% ropivacaine with epinephrine 1:200.000 2% lidocaine with epinephrine 1:100.000

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

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes