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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable / Topical | Experimental | Half of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable | Drug | 20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Anesthetic Preference | Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. | one week post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Diepenbrock, DDS | USAF David Grant Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USAF David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19735519 | Background | 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. | |
| 19337944 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injectable / Topical | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
one participant dropped out before follow up visit. We were not able to get complete data on this participant so we did not use their information
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One participant dropped out before her follow up visit. We were not able to get complete data on this participant so we did not use her information. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Anesthetic Preference | Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. | Posted | Number | participant preference selection | one week post treatment |
|
one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injectable / Topical | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncopal Episode | Vascular disorders | Systematic Assessment | Participant had just received his HA filler treatment when he had a syncopal episode. He was still sitting in chair it lasted approximately 30 seconds. He was treated per OMFS department protocol. He was fully recovered before he left the clinic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason May | Travis AFB OMFS Clinic | 707-423-7085 | jason.may.11@us.af.mil |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000760 | Anesthesia and Analgesia |
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| Topical | Drug | 4% Topicaine gel |
|
|
| 5-10 minutes post-procedure |
| 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 | 5-10 min post procedure |
| 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 | 5-10 minutes post procedure |
| 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. | 5-10 minutes post procedure |
| 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 | 5-10 minutes post procedure |
| 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. |
| 19207322 | Background | 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. |
| 16416650 | Background | 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. |
| 20538398 | Background | 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. |
| 21211888 | Background | 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. |
| 23997477 | Background | 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. |
| 24097340 | Background | 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. |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | One participant dropped out before completing study. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | unit on a scale | 5-10 minutes post-procedure |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 5-10 min post procedure |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 5-10 minutes post procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 5-10 minutes post procedure |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 5-10 minutes post procedure |
|
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|
| 0 |
| 49 |
| 1 |
| 49 |
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