Split Face Study of the Duration of Local Anesthetics - Fifth Arm

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: This Study Will Focus on In-office Dermatological Procedures
• Intervention / Treatment: Drug: Lidocaine HCl/Epinephrine

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kira Minkis, MD, PhD; Phone Number: 6469627948; Email: kim9036@med.cornell.edu
• Study Contact Backup: Name: Fengrui Zhan, BS; Phone Number: 6073797248; Email: fez4003@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
      • Principal Investigator: Kira Minkis, MD, PhD
      • Contact: Fengrui Zhan, BS; Phone Number: 6073797248; Email: fez4003@med.cornell.edu
      • Contact: Kira Minkis, MD, PhD; Phone Number: 646-962-7948; Email: kim9036@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intradermal administration of 0.5mL of lidocaine	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.
Experimental: Subcutaneous administration of 0.5mL of lidocaine	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.
Experimental: Intradermal administration of 1.0mL of lidocaine	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.
Experimental: Subcutaneous administration of 1.0mL of lidocaine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of anesthesia	Time (in minutes) from onset of anesthesia (loss of sharp sensation at the injection site) to return of sharp sensation.	From injection until return of sharp sensation, up to 6 hours
Onset of anesthesia	Duration (in minutes) between anesthetic administration to loss of sensation to sharpness at injection site.	Immediately following injection until loss of sharp sensation, up to 10 minutes

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Kira Minkis, MD, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 22-10025244-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No