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

NCT ID: NCT02379221

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed 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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injectable / Topical

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

Group Type: EXPERIMENTAL

Injectable

Intervention Type: DRUG

20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection

Topical

Intervention Type: DRUG

4% Topicaine gel

Interventions

Injectable

20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection

Intervention Type: DRUG

Topical

4% Topicaine gel

Intervention Type: DRUG

Other Intervention Names

benzocaine gel-lidocaine-epinephrine nerve block injection; topical anesthesia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

David Grant U.S. Air Force Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Diepenbrock, DDS

Role: STUDY_CHAIR

USAF David Grant Medical Center

Locations

USAF David Grant Medical Center

Travis Air Force Base, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 19735519 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

FDG20140012H

Identifier Type: -

Identifier Source: org_study_id