Local Anaesthetic Complication, Pain
Conditions
Keywords
lidocaine, vibration, anesthesia, injection, pain, discomfort, dermatology, dermatologic surgery, local, device
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
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.
Interventions
DEVICEKinetic 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
OTHERControl
One injection will be administered without the kinetic anesthesia device.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of Lidocaine Injection, Measured by Visual Analog Scale. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference for Injection With or Without Kinetic Anesthesia Device | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
This was a split body study, so each participant functioned in both intervention and control arms.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 26 years |
| Race/Ethnicity, Customized Self-identified race and ethnicity African-American | 5 Participants |
| Race/Ethnicity, Customized Self-identified race and ethnicity Asian | 13 Participants |
| Race/Ethnicity, Customized Self-identified race and ethnicity Native American | 1 Participants |
| Race/Ethnicity, Customized Self-identified race and ethnicity White (hispanic) | 8 Participants |
| Race/Ethnicity, Customized Self-identified race and ethnicity White (non-hispanic) | 20 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
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.
Time frame: This measurement will occur immediately after each injection
Population: See above
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Injections Using the Kinetic Anesthesia Device | Pain of Lidocaine Injection, Measured by Visual Analog Scale. | 7.5 mm on visual analog scale |
| Injections Without Kinetic Anesthesia Device | Pain of Lidocaine Injection, Measured by Visual Analog Scale. | 26 mm on visual analog scale |
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.
Time frame: This will occur immediately after the second injection
Population: 45 participants filled out this portion of the post-injection questionnaire, while two neglected this portion of the questionnaire.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injections Using the Kinetic Anesthesia Device | Patient Preference for Injection With or Without Kinetic Anesthesia Device | 33 Participants |
| Injections Without Kinetic Anesthesia Device | Patient Preference for Injection With or Without Kinetic Anesthesia Device | 6 Participants |