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

• Sponsor: David Grant U.S. Air Force Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02379221
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 2.6

Study Details

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	N/A

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

• Study Type: Interventional
• 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: Sep 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Apr 1, 2016

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 Names: benzocaine gel-lidocaine-epinephrine nerve block injection ; Drug: Topical; 4% Topicaine gel; Other Names: topical anesthesia

Outcome Measures

Primary Outcome Measures

1. Participants Anesthetic Preference [one week post treatment]

   Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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.

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: David Grant U.S. Air Force Medical Center
• ClinicalTrials.gov Identifier: NCT02379221
• Other Study ID Numbers: FDG20140012H
• First Posted: Mar 4, 2015
• Last Update Posted: Apr 29, 2020
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lidocaine; Epinephrine; Benzocaine

Study Results

Participant Flow

Arm/Group Title	Injectable / Topical
Arm/Group Description	Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia per randomized method. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Period Title: Overall Study
STARTED	49
COMPLETED	48
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Injectable / Topical
Arm/Group Description	Half of the face is injected with local anesthesia, the other half is treated with topical anesthesia by randomized method. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
Overall Participants	48
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	48 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53
Sex: Female, Male (Count of Participants)
Female	46 95.8%
Male	2 4.2%
Region of Enrollment (participants) [Number]
United States	48 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectable	Topical
Arm/Group Description	Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Measure Participants	48	48
Number [participant preference selection]	32	16

2. Secondary Outcome

Title	Mean Pain Level Associated With the Local Anesthetic Injection
Description	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
Time Frame	5-10 minutes post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Lip	Lower Lip
Arm/Group Description	2% lidocaine and 1:100k epinephrine injected to the upper lip	2% lidocaine and 1:100K epi injected to the lower lip
Measure Participants	48	48
Mean (Standard Deviation) [unit on a scale]	2.14 (2.35)	1.89 (2.04)

3. Secondary Outcome

Title	Mean Pain Level Associated With the Local Topical Anesthetic
Description	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
Time Frame	5-10 min post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Upper Lip	Lower Lip
Arm/Group Description	20% benzocaine to the upper lip	20% benzocaine to the lower lip
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	0.05 (.21)	0.11 (.32)

4. Secondary Outcome

Title	Mean Pain Level Associated With Facial Filler Injection at the Upper Lip
Description	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
Time Frame	5-10 minutes post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectable	Topical
Arm/Group Description	Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	0.89 (1.60)	3.67 (2.87)

5. Secondary Outcome

Title	Mean Pain Level Associated With Facial Filler Injection to the Lower Lip
Description	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.
Time Frame	5-10 minutes post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectable	Topical
Arm/Group Description	Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	1.47 (2.41)	4.38 (2.95)

6. Secondary Outcome

Title	Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold
Description	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
Time Frame	5-10 minutes post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectable	Topical
Arm/Group Description	Half of the face is injected with local anesthesia per randomized method. Injectable: 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel	Half of the face is treated with topical anesthesia per randomized method Topical application of 20% benzocaine 4% lidocaine gel
Measure Participants	48	48
Mean (Standard Deviation) [units on a scale]	0.76 (1.49)	2.82 (2.54)

Adverse Events

Time Frame	one week
Arm/Group Title	Injectable / Topical
Arm/Group Description	One side of face is injected with local anesthesia, the other side is treated with topical anesthesia per randomization. Injectable: 20% benzocaine, 2% lidocaine 1:100k epinephrine nerve block injection Topical: 4% Topicaine gel
All Cause Mortality
	Injectable / Topical
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Injectable / Topical
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Injectable / Topical
	Affected / at Risk (%)	# Events
Total	1/49 (2%)
Vascular disorders
Syncopal Episode	1/49 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.