Anesthesia
Conditions
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.
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.
Interventions
DRUGInjectable
20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection
DRUGTopical
4% Topicaine gel
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Anesthetic Preference | one week post treatment | Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Injectable / Topical 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 | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Injectable / Topical |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 53 years |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Participants Anesthetic Preference
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.
Time frame: one week post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Injectable | Participants Anesthetic Preference | 32 participant preference selection |
| Topical | Participants Anesthetic Preference | 16 participant preference selection |
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
Time frame: 5-10 minutes post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injectable | Mean Pain Level Associated With Facial Filler Injection at the Upper Lip | 0.89 units on a scale | Standard Deviation 1.6 |
| Topical | Mean Pain Level Associated With Facial Filler Injection at the Upper Lip | 3.67 units on a scale | Standard Deviation 2.87 |
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.
Time frame: 5-10 minutes post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injectable | Mean Pain Level Associated With Facial Filler Injection to the Lower Lip | 1.47 units on a scale | Standard Deviation 2.41 |
| Topical | Mean Pain Level Associated With Facial Filler Injection to the Lower Lip | 4.38 units on a scale | Standard Deviation 2.95 |
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
Time frame: 5-10 minutes post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injectable | Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold | 0.76 units on a scale | Standard Deviation 1.49 |
| Topical | Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold | 2.82 units on a scale | Standard Deviation 2.54 |
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
Time frame: 5-10 minutes post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injectable | Mean Pain Level Associated With the Local Anesthetic Injection | 2.14 unit on a scale | Standard Deviation 2.35 |
| Topical | Mean Pain Level Associated With the Local Anesthetic Injection | 1.89 unit on a scale | Standard Deviation 2.04 |
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
Time frame: 5-10 min post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injectable | Mean Pain Level Associated With the Local Topical Anesthetic | 0.05 units on a scale | Standard Deviation 0.21 |
| Topical | Mean Pain Level Associated With the Local Topical Anesthetic | 0.11 units on a scale | Standard Deviation 0.32 |