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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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

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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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



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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

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
Publications:

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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