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

Not Applicable

Completed

Conditions: Anesthesia

Interventions: Drug: Injectable
Drug: Topical

Registration Number: NCT02379221

Lead Sponsor: David Grant U.S. Air Force Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Participants Anesthetic Preference	one week post treatment	Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

Secondary Outcome Measures

Name	Time	Method
Mean Pain Level Associated With the Local Anesthetic Injection	5-10 minutes post-procedure	Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm
Mean Pain Level Associated With the Local Topical Anesthetic	5-10 min post procedure	Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm
Mean Pain Level Associated With Facial Filler Injection at the Upper Lip	5-10 minutes post procedure	Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm
Mean Pain Level Associated With Facial Filler Injection to the Lower Lip	5-10 minutes post procedure	A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48.
Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold	5-10 minutes post procedure	Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm