Expired Study
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Travis AFB, California 94535


Purpose:

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 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.


Study summary:

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 randomized controlled trial. 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-op to determine overall pain perceptions from each method of facial anesthesia.


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


NCT ID:

NCT02379221


Primary Contact:

Study Chair
Ryan Diepenbrock, DDS
USAF David Grant Medical Center


Backup Contact:

N/A


Location Contact:

Travis AFB, California 94535
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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