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

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ClinicalTrials.gov Identifier: NCT02379221

Recruitment Status : Completed

First Posted : March 4, 2015

Results First Posted : October 24, 2018

Last Update Posted : April 29, 2020

Sponsor:

Information provided by (Responsible Party):

David Grant U.S. Air Force Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Injectable Drug: Topical	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	49 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers
Study Start Date :	September 2014
Actual Primary Completion Date :	March 2016
Actual Study Completion Date :	April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Drug Information available for: Epinephrine Lidocaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Injectable 20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection Other Name: benzocaine gel-lidocaine-epinephrine nerve block injection Drug: Topical 4% Topicaine gel Other Name: topical anesthesia

Outcome Measures

Primary Outcome Measures :

Participants Anesthetic Preference [ Time Frame: one week post treatment ]
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

Secondary Outcome Measures :

Mean Pain Level Associated With the Local Anesthetic Injection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379221

Locations

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United States, California
USAF David Grant Medical Center
Travis Air Force Base, California, United States, 94535

Sponsors and Collaborators

David Grant U.S. Air Force Medical Center

Investigators

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Study Chair:	Ryan Diepenbrock, DDS	USAF David Grant Medical Center

More Information

Publications:

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 Juvéderm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.

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.

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.

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.

López-Jornet P, Camacho-Alonso F, Martinez-Canovas A. Clinical evaluation of polyvinylpyrrolidone sodium hyaluronate gel and 0.2% chlorhexidine gel for pain after oral mucosa biopsy: a preliminary study. J Oral Maxillofac Surg. 2010 Sep;68(9):2159-63. doi: 10.1016/j.joms.2009.09.047. Epub 2010 Jun 11.

Kim YK, Kim SG, Kim JH. Altered sensation after orthognathic surgery. J Oral Maxillofac Surg. 2011 Mar;69(3):893-8. doi: 10.1016/j.joms.2010.10.025. Epub 2011 Jan 6.

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.

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.

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Responsible Party:	David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:	NCT02379221
Other Study ID Numbers:	FDG20140012H
First Posted:	March 4, 2015 Key Record Dates
Results First Posted:	October 24, 2018
Last Update Posted:	April 29, 2020
Last Verified:	September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Lidocaine Epinephrine Benzocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

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