This Study Will Focus on In-office Dermatological Procedures
Conditions
Brief summary
This study will compare how long local anesthesia lasts when it is injected into different layers of the skin on the forearm. The investigators hypothesize that the numbing effect will last for different amounts of time depending on whether the medication is injected just under the skin or into the skin itself.
Detailed description
This study will compare the relative duration and efficacy of a commonly used local anesthetic (lidocaine with epinephrine) when administered into different layers of the skin on the ventral forearm within the same participant. Specifically, injections will be placed in the intradermal and subcutaneous tissue. A modification of a previously published noninvasive pinprick testing method will be used to assess the duration of local anesthesia. The investigators hypothesize that the duration of anesthesia will differ depending on the depth of injection, with intradermal and subcutaneous administration producing different durations of anesthetic effect. This study record uses the same protocol document of a previous study under Clinical Trials record NCT06694714, but documents a fifth arm for which data will be analyzed separately from data in NCT06694714.
Interventions
DRUGLidocaine HCl/Epinephrine
Injection of lidocaine solution for local anesthesia. Participants will receive lidocaine via either intradermal or subcutaneous administration at a volume of 0.5 mL or 1.0 mL.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female ≥ 18 years of age * Normal skin sensation at both nasal ala and volar forearms assessed by pinprick * Ability to provide informed consent
Exclusion criteria
* Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated * Pregnant or breastfeeding volunteers (assessed by self-report) * Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of anesthesia | From injection until return of sharp sensation, up to 6 hours | Time (in minutes) from onset of anesthesia (loss of sharp sensation at the injection site) to return of sharp sensation. |
| Onset of anesthesia | Immediately following injection until loss of sharp sensation, up to 10 minutes | Duration (in minutes) between anesthetic administration to loss of sensation to sharpness at injection site. |
Countries
United States
Contacts
CONTACTKira Minkis, MD, PhD
CONTACTFengrui Zhan, BS
PRINCIPAL_INVESTIGATORKira Minkis, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed