Split Face Study of the Duration of Local Anesthetics - Fifth Arm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine HCl/Epinephrine.
- Who it may be relevant to
- Registry conditions: This Study Will Focus on In-office Dermatological Procedures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery
Overview
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
- Drug Lidocaine 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.
Primary outcome measures
- Duration of anesthesia [Time frame: From injection until return of sharp sensation, up to 6 hours]
- Onset of anesthesia [Time frame: Immediately following injection until loss of sharp sensation, up to 10 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT07724418 · 22-10025244-2