Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers.

David Grant U.S. Air Force Medical Center

Status: Completed

Conditions: Anesthesia

Treatments: Drug: Topical; Drug: Injectable

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02379221

FDG20140012H

Details and patient eligibility

About

The purpose of the study is to compare two modalities of local anesthetic administration prior to the placement of cosmetic facial injectable fillers. Both short and long term pain perceptions for the facial filler procedure will be compared in patients receiving 4% Topicaine gel on half their face, and 20% benzocaine gel prior to 2% lidocaine 1:100k epinephrine nerve block injections on the other half of their face. The objective is to quantify the subjective pain experienced by these two modalities of local anesthetic during the procedure of Juvederm XC filler injections.

Full description

The purpose of this study is to determine if local anesthesia injections will provide more profound analgesia than topical anesthesia during facial cosmetic filler injections. The study is a single group study design. The attending surgeon or residents will perform the procedure. Each procedure will start with a randomized coin flip to determine which side of the face will be anesthetized with local anesthesia or topical anesthesia. The head side of the coin will coincide with local anesthesia on the patient's right side. The tail of the coin will designate the patient's left side for local anesthetic injections.

To evaluate whether the additional anesthesia of a nerve block brings more pain relief than the initial pain of receiving a nerve block, the pain value will be collected from each nerve block administered. Procedural injection pain data will be collected from the nerve blocked facial half and from the topical anesthetic facial half to provide a comparison of anesthesia during the procedure. The primary outcome will be the collection of "overall" pain data from each side of the face 5-10 minutes after the procedure. Facial anesthesia preference data will also be collected at one week post treatment to determine overall pain perceptions from each method of facial anesthesia.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• Patients with deepened labiomental folds or decreased lip volume and architecture who are scheduled to receive Juvederm XC injections in DGMC Oral & Maxillofacial Surgery clinic.

Exclusion criteria

• Pregnant or nursing
• History of any type of neuralgia or paresthesia, or paresis
• Allergy or contraindication to lidocaine or hyaluronic acid
• Use of hyaluronic acid in last 6 months
• Previous reaction to Juvederm or other hyaluronic acid based fillers
• Have an active inflammatory or infectious process at the injection site.
• Use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants
• Severe coronary artery disease
• Diagnosis of any cardiac dysrhythmia with an ECG finding other than normal sinus rhythm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Injectable / Topical

Experimental group

Description:

Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.

Treatment:

Drug: Injectable

Drug: Topical