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AnesthesiaNCT02379221

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

A study testing Injectable and Topical in people with Anesthesia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Injectable and Topical
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
Sep 2014to Apr 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USAF David Grant Medical Center

    Travis Air Force Base, California, 94535

Other trials in United States

About this study

Official title: Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers

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.

Read the 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.

Conditions
Anesthesia
Being tested
Injectable, Topical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InjectableDrug

    Also called benzocaine gel-lidocaine-epinephrine nerve block injection

    20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection

  • TopicalDrug

    Also called topical anesthesia

    4% Topicaine gel

Study groups in NCT02379221
Study groupRoleWhat they receive
Injectable / TopicalExperimentalHalf of the face is injected with local anesthesia (lidocaine-epinephrine), the other half is treated with topical anesthesia (topicaine gel) per randomize method.
Receives: Drug: Injectable; Drug: Topical

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants Anesthetic Preference

    Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.

    Measured: one week post treatment

Secondary outcomes (5)

  1. 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

    Measured: 5-10 minutes post-procedure

  2. 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

    Measured: 5-10 min post procedure

  3. 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

    Measured: 5-10 minutes post procedure

  4. 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.

    Measured: 5-10 minutes post procedure

  5. 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

    Measured: 5-10 minutes post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379221
Sponsor's protocol ID
FDG20140012H
Status last verified
Sep 2018
First submitted
27 Feb 2015
Last updated
29 Apr 2020
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 19735519

  • 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.

    PubMed 19337944

  • 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.

    PubMed 19207322

  • 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.

    PubMed 16416650

  • 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.

    PubMed 20538398

  • 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.

    PubMed 21211888

  • 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.

    PubMed 23997477

  • 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.

    PubMed 24097340

Questions about this trial

What is this clinical trial studying?

A study testing Injectable and Topical in people with Anesthesia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Anesthetic Preference (time frame: one week post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379221, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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