Anesthesia, Local, Dermatology/Skin - Other, Pain, Acute
Conditions
Brief summary
Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.
Interventions
This is a handheld \ 10cm long tool, battery operated, which provides vibration at a rate of \ 150 Hz
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Subjects will be asked to close their eyes prior to the vibration anesthetic device (VAD) being applied to their skin. Only the user will know whether the VAD will be on or off based on the result of a random number generator. This will prevent anticipatory changes on the subjects side. The subject will be aware of the intervention after the device is turned on or left in the off position.
Intervention model description
Subjects will be randomly assigned into one of two groups: Group 1: Vibratory anesthetic device (VAD) is in the OFF mode Group 2: VAD is in the ON mode We will use a random number generator to place patients into one of the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients
Exclusion criteria
* Patients less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Score | Within 5 seconds of injection | This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAD Off Arm This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration
Vibratory Anesthetic Device (VAD): This is a handheld \
10cm long tool, battery operated, which provides vibration at a rate of \
150 Hz | 52 |
| VAD On Arm This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration
Vibratory Anesthetic Device (VAD): This is a handheld \
10cm long tool, battery operated, which provides vibration at a rate of \
150 Hz | 49 |
| Total | 101 |
Baseline characteristics
| Characteristic | VAD Off Arm | VAD On Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 21 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 28 Participants | 52 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 1.1 | 66 years STANDARD_DEVIATION 1.1 | 66 years STANDARD_DEVIATION 1.1 |
| Location of treatment on body Head and Neck | 38 Participants | 34 Participants | 72 Participants |
| Location of treatment on body Trunk Extremities | 14 Participants | 15 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 52 participants | 49 participants | 101 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 32 Participants | 32 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 49 |
| other Total, other adverse events | 0 / 52 | 0 / 49 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 |
Outcome results
Primary
Numeric Rating Score
This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain.
Time frame: Within 5 seconds of injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VAD Off Arm | Numeric Rating Score | 2.0 score on a scale | Standard Deviation 0.4 |
| VAD On Arm | Numeric Rating Score | 1.2 score on a scale | Standard Deviation 0.2 |
p-value: <0.05t-test, 2 sided