Pain
Conditions
Brief summary
This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception. This study is a pilot study designed to determine feasibility of these procedures.
Interventions
PROCEDURESlow, Room Temperature Injection
The room temperature local anesthetic agent will be administered by slow infiltration.
PROCEDURERapid, Room Temperature Injection
The room temperature local anesthetic agent will be administered by rapid infiltration.
PROCEDURESlow, Warm Temperature Injection
The warmed local anesthetic agent will be administered by slow infiltration.
PROCEDURERapid, Warm Temperature Injection
The warmed local anesthetic agent will be administered by rapid infiltration.
PROCEDUREBuffered Injection
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
PROCEDURENon-Buffered Injection
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
DRUGLidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
DRUGBuffer
Sodium Bicarbonate
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who are undergoing dermatologic procedures. * Subjects ages 18-89 year old. * The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.
Exclusion criteria
* Subjects who are allergic to lidocaine. * History of bleeding tendency or coagulopathy. * Pregnant or lactating. * Active skin disease or skin infection in the treatment area. * Unable to understand the protocol or give informed consent. * Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on a Visual Analog Scale (VAS) | intraoperative | Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful. |
Countries
United States
Outcome results
None listed