Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph F Sobanko, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
This was a split body study, so each participant functioned in both intervention and control arms.
Healthy volunteers were recruited from the area surrounding the University of Pennsylvania using IRB-approved flyers, as well as approved email communications, and postings on an approved website
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Injection (5 Minutes) |
| ||||||||||||||||
| Wash Out (10 Minutes |
| ||||||||||||||||
| Second Injection (5 Minutes) |
|
This was a split body study, meaning that each participant was a part of both the "KAD" arm and the control arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received two lidocaine injections - one on the left and one on the right side of the body, with the left side injection always administered first. One of the injections was performed with the kinetic anesthesia device assistance, while the other was performed without (the control injection). As noted in the protocol, participants were randomized to receive the kinetic anesthesia device assisted injection first or second. 21 participants received the kinetic anesthesia device assisted injection first, while 26 were randomized to receive it second. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | See above | Posted | Median | Inter-Quartile Range | mm on visual analog scale | This measurement will occur immediately after each injection |
|
1 Hour
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants received two lidocaine injections - one on the left and one on the right side of the body, with the left side injection always administered first. One of the injections was performed with the kinetic anesthesia device assistance, while the other was performed without (the control injection). As noted in the protocol, participants were randomized to receive the kinetic anesthesia device assisted injection first or second. 21 participants received the kinetic anesthesia device assisted injection first, while 26 were randomized to receive it second. 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Sobanko | Perelman School of Medicine at the University of Pennsylvania | 215.360.0909 | joseph.sobanko@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2017 | Dec 10, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Control | Other | One injection will be administered without the kinetic anesthesia device. |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Injections Without Kinetic Anesthesia Device | Participants graded the pain of lidocaine injection with no intervention |
|
|
| Secondary | 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. | 45 participants filled out this portion of the post-injection questionnaire, while two neglected this portion of the questionnaire. | Posted | Count of Participants | Participants | This will occur immediately after the second injection |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
Not provided
Not provided