Kinetic Anesthesia Device Study

March 9, 2019 updated by: Joseph F Sobanko M.D., University of Pennsylvania

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

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

Study Overview

Detailed 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. 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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult volunteers greater than or equal to 18 years of age
  2. Able and willing to provide informed consent
  3. Able to comprehend and comply with study instructions, and able to complete necessary evaluations.

Exclusion Criteria:

  1. Patients unable or unwilling to provide informed consent.
  2. Patients with lidocaine allergy
  3. Patients with known pain-related or neurological condition.
  4. Patients with a known cardiac condition
  5. Vulnerable populations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinetic anesthesia device, then no intervention
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
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
One injection will be administered without the kinetic anesthesia device.
Experimental: No intervention, then kinetic anesthesia device
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.
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
One injection will be administered without the kinetic anesthesia device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of Lidocaine Injection, Measured by Visual Analog Scale.
Time Frame: This measurement will occur immediately after each injection
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
Time Frame: This will occur immediately after the second injection

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph F Sobanko, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

January 27, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 9, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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