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Completed

NCT Number: NCT02379221

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USAF David Grant Medical Center

Travis Air Force Base, California, 94535, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injectable

Drug

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

Other names: benzocaine gel-lidocaine-epinephrine nerve block injection

Topical

Drug

4% Topicaine gel

Other names: topical anesthesia

Primary outcomes

  1. Participants Anesthetic Preference

    Time frame: one week post treatment

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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. 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

Sponsors and collaborators

Lead sponsor

David Grant U.S. Air Force Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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