Kinetic Anesthesia Device Study

Study Overview
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Brief Summary
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Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. We will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

Detailed Description
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The study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the University of Pennsylvania, and from the University City area of Philadelphia. Participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. Participants will then be randomized to receive injection with the KAD first or second. The injection will be 0.5 cc of room temperature buffered lidocaine injected at constant slow speed (approximately 5 seconds) through a 30-gage needle held perpendicular to the skin by the same surgeon, with verbal cues standardized. Injections will be given in accordance with the standard of practice. When the KAD is used it will be used as directed: firmly pressed on the skin adjacent to the injection, with the needle aimed into the lighted area. Volunteers will evaluate each injection immediately after it is complete using the visual analog scale. When both injections are completed, participants will indicate their preference of injection, complete qualitative questions, and note necessary demographic information. Injection location and order of intervention (i.e. first or second) will be noted.

Official Title
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Kinetic Anesthesia Device for Lidocaine Injection: a Randomized Split-body Study of the Effects of Kinetic Anesthesia Devices on Pain of Lidocaine Injection in Healthy Volunteers

Conditions
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Pain, Local Anaesthetic Complication

Intervention / Treatment
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* Device: Kinetic Anesthesia Device
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult volunteers greater than or equal to 18 years of age Able and willing to provide informed consent Able to comprehend and comply with study instructions, and able to complete necessary evaluations. Exclusion Criteria: Patients unable or unwilling to provide informed consent. Patients with lidocaine allergy Patients with known pain-related or neurological condition. Patients with a known cardiac condition Vulnerable populations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the University of Pennsylvania, and from the University City area of Philadelphia. Participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. Participants will then be randomized to receive injection with the KAD first or second. They will receive one injection with and one injection without the interventional device, in a randomized order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinetic anesthesia device, then no intervention<br>In this arm of the crossover study, participants will receive lidocaine injection in conjunction with the kinetic anesthesia device, then will receive an injection without the kinetic anesthesia device intervention | Device: Kinetic Anesthesia Device<br>* A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain<br>Other: Control<br>* One injection will be administered without the kinetic anesthesia device.<br>|
| Experimental: No intervention, then kinetic anesthesia device<br>In this arm of the crossover study, participants will receive lidocaine injection without the kinetic anesthesia device intervention, then will receive an injection in conjunction with the kinetic anesthesia device. | Device: Kinetic Anesthesia Device<br>* A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain<br>Other: Control<br>* One injection will be administered without the kinetic anesthesia device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of Lidocaine Injection, Measured by Visual Analog Scale. | Participants will be asked to mark the pain of injection on a 100mm visual analog scale. The visual analog scale is commonly used to measure acute pain, though it can be used in other settings. It consists of a line 100mm long. The left end is labeled no pain at all and the right end is labeled worst pain imaginable. Participants will rate pain by marking the scale where they feel that their level of pain falls on the scale. The length from 0 to the participant's mark will be measured in millimeters (for a range of 0 to 100 mm possible). Higher numbers will be considered more pain. | This measurement will occur immediately after each injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference for Injection With or Without Kinetic Anesthesia Device | Qualitative measure of patient preference for injections with or without the kinetic anesthesia device. Participants were asked whether they preferred the injection with or without the kinetic anesthesia device. Counts below indicate the number of participants who preferred each type of injection. | This will occur immediately after the second injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, vibration, anesthesia, injection, pain, discomfort, dermatology, dermatologic surgery, local, device