Clinical trial NCT02379221: Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers.
Official title: Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2015-03-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participants Anesthetic Preference
timeFrame: one week post treatment
Secondary outcomes:
measure: Mean Pain Level Associated With the Local Anesthetic Injection
timeFrame: 5-10 minutes post-procedure
measure: Mean Pain Level Associated With the Local Topical Anesthetic
timeFrame: 5-10 min post procedure
measure: Mean Pain Level Associated With Facial Filler Injection at the Upper Lip
timeFrame: 5-10 minutes post procedure
measure: Mean Pain Level Associated With Facial Filler Injection to the Lower Lip
timeFrame: 5-10 minutes post procedure
measure: Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold
timeFrame: 5-10 minutes post procedure
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: USAF David Grant Medical Center
state: California
Study officials:
affiliation: USAF David Grant Medical Center
name: Ryan Diepenbrock, DDS
role: STUDY_CHAIR
References:
citation: Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.
citation: Levy PM, De Boulle K, Raspaldo H. A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds. J Cosmet Laser Ther. 2009 Sep;11(3):169-73. doi: 10.1080/14764170902833142.
citation: Levy PM, De Boulle K, Raspaldo H. Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and a hyaluronic acid filler alone. Dermatol Surg. 2009 Feb;35 Suppl 1:332-6; discussion 337. doi: 10.1111/j.1524-4725.2008.01045.x.
citation: Smith KC, Melnychuk M. Five percent lidocaine cream applied simultaneously to the skin and mucosa of the lips creates excellent anesthesia for filler injections. Dermatol Surg. 2005 Nov;31(11 Pt 2):1635-7. doi: 10.2310/6350.2005.31253.
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citation: Maria A, Malik M, Virang P. Comparison of primary and secondary closure of the surgical wound after removal of impacted mandibular third molars. J Maxillofac Oral Surg. 2012 Sep;11(3):276-83. doi: 10.1007/s12663-011-0287-9. Epub 2011 Sep 23.
citation: Brajkovic D, Brkovic B, Milic M, Biocanin V, Krsljak E, Stojic D. Levobupivacaine vs. bupivacaine for third molar surgery: quality of anaesthesia, postoperative analgesia and local vascular effects. Clin Oral Investig. 2014;18(5):1481-8. doi: 10.1007/s00784-013-1114-0. Epub 2013 Oct 6.