Kinetic Anesthesia Device Study

NCT03344510 | Completed Results FDA Device

• 1 other identifier: 828686
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Local Anaesthetic Complication; Pain

Keywords

lidocaine; vibration; anesthesia; injection; pain; discomfort; dermatology; dermatologic surgery; local; device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Preference for Injection With or Without Kinetic Anesthesia Device

  This will occur immediately after the second injection

Study Arms (2)

Kinetic anesthesia device, then no intervention

EXPERIMENTAL

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; Other: Control

No intervention, then kinetic anesthesia device

EXPERIMENTAL

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; Other: Control

Interventions

Kinetic Anesthesia Device 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

Kinetic anesthesia device, then no intervention; No intervention, then kinetic anesthesia device

Control OTHER

One injection will be administered without the kinetic anesthesia device.

Kinetic anesthesia device, then no intervention; No intervention, then kinetic anesthesia device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Joseph Sobanko
• Organization: Perelman School of Medicine at the University of Pennsylvania

joseph.sobanko@uphs.upenn.edu

215.360.0909

Study Officials

• Joseph F Sobanko, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dermatology

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: January 23, 2017
• Primary Completion: January 27, 2018
• Study Completion: May 30, 2018
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)