N/A
N=49
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers.
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02379221 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Participants Anesthetic Preference — 32; 16 participant preference selection
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Injectable (Drug); Topical (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Grant U.S. Air Force Medical Center
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Anesthetic Preference |
32; 16 | — |
| SECONDARY Mean Pain Level Associated With the Local Anesthetic Injection |
2.14; 1.89 | — |
| SECONDARY Mean Pain Level Associated With the Local Topical Anesthetic |
0.05; 0.11 | — |
| SECONDARY Mean Pain Level Associated With Facial Filler Injection at the Upper Lip |
0.89; 3.67 | — |
| SECONDARY Mean Pain Level Associated With Facial Filler Injection to the Lower Lip |
1.47; 4.38 | — |
| SECONDARY Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold |
0.76; 2.82 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02379221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.