NCT06694714

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	0.5 ml lidocaine + epinephrine 1:100,000	0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb
DRUG	1.0 ml lidocaine + epinephrine 1:100,000	1.0 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb

Timeline

• Start date: 2025-01-21
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-11-19
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study