- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379221
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers.
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Travis Air Force Base, California, United States, 94535
- USAF David Grant Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection
Other Names:
4% Topicaine gel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Anesthetic Preference
Time Frame: one week post treatment
|
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.
|
one week post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5-10 minutes post-procedure
|
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
|
5-10 min post procedure
|
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
|
5-10 minutes post procedure
|
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.
|
5-10 minutes post procedure
|
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
|
5-10 minutes post procedure
|
Collaborators and Investigators
Investigators
- Study Chair: Ryan Diepenbrock, DDS, USAF David Grant Medical Center
Publications and helpful links
General 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 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.
- 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. doi: 10.2310/6350.2005.31253.
- Lopez-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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Epinephrine
- Benzocaine
Other Study ID Numbers
- FDG20140012H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Matthew BorzageRecruitingAnesthesia | Anesthesia; ReactionUnited States
Clinical Trials on Injectable
-
Ain Shams UniversityRecruiting
-
Psoriasis Treatment Center of Central New JerseySun Pharmaceutical Industries LimitedUnknown
-
Fayoum UniversityCompleted
-
Cook Group IncorporatedCompletedPeripheral Arterial Disease | Peripheral Vascular Disease | Critical Limb IschemiaCzechia
-
AbbVieRecruiting
-
Tang-Du HospitalRecruitingMyasthenia Gravis, GeneralizedChina
-
AllerganCompletedSoft Tissue AugmentationFrance
-
Merz North America, Inc.CompletedVolume Loss of the Jawline
-
Achieve Life SciencesCompletedBreast Neoplasms | Lung Neoplasms | Colorectal Neoplasms | Pancreatic Neoplasms | Pelvic NeoplasmsUnited States
-
Boston Scientific CorporationCompleted