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NCT Number: NCT06694714

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

This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

The investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. The investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. Specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. The investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. The investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face.

This study record uses the same protocol document of a previous study under Clinical Trials record NCT05767749, but documents a fourth arm for which data will be analyzed separately from data in NCT05767749

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥ 18 years of age
  • Normal skin sensation at both nasal ala 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

Treatment and study plan

0.5 ml lidocaine + epinephrine 1:100,000

Drug

0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb

1.0 ml lidocaine + epinephrine 1:100,000

Drug

1.0 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb

Primary outcomes

  1. Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments

    Time frame: Up to 4 hours.

    To determine whether the time to return to baseline sensation differs significantly between each pair of anesthetics, the investigators will measure the time to return to baseline sensation at each anesthetized site by asking participants at 15 minute intervals if they can feel a sharp sensation at the site. Sterile needles will be used. The return of the sensitivity will be determined using binary outcomes (yes/no) and recorded on a standardized template. The maximum difference in anesthetic duration that the investigators consider "not different" from a clinical standpoint is 15 minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedict Ho, BA

CONTACT

[email protected]

646-962-6647

Kira Minkis, MD PhD

CONTACT

[email protected]

646-962-6647

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery - Fourth Arm

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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