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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379221
• Other study ID #: FDG20140012H
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2018
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Injectable
20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection
• Topical
4% Topicaine gel

Locations

Country	Name	City	State
United States	USAF David Grant Medical Center	Travis Air Force Base	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Anesthetic Preference	Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.	one week post treatment
Secondary	Mean Pain Level Associated With the Local Anesthetic Injection	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	5-10 minutes post-procedure
Secondary	Mean Pain Level Associated With the Local Topical Anesthetic	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	5-10 min post procedure
Secondary	Mean Pain Level Associated With Facial Filler Injection at the Upper Lip	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	5-10 minutes post procedure
Secondary	Mean Pain Level Associated With Facial Filler Injection to the Lower Lip	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.	5-10 minutes post procedure
Secondary	Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold	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	5-10 minutes post procedure