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

NCT ID: NCT06694714

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2027-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine

Each side of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) and 1.0 ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala. Laterality of each anesthetic volume administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.

Group Type: EXPERIMENTAL

0.5 ml lidocaine + epinephrine 1:100,000

Intervention Type: DRUG

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

1.0 ml lidocaine + epinephrine 1:100,000

Intervention Type: DRUG

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

1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine

Each side of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 1.0ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) and 0.5 ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala. Laterality of each anesthetic volume administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes on both sides of the face, until the patient reports return of a sharp sensation upon the pinprick test.

Group Type: EXPERIMENTAL

0.5 ml lidocaine + epinephrine 1:100,000

Intervention Type: DRUG

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

1.0 ml lidocaine + epinephrine 1:100,000

Intervention Type: DRUG

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

Interventions

0.5 ml lidocaine + epinephrine 1:100,000

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

Intervention Type: DRUG

1.0 ml lidocaine + epinephrine 1:100,000

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kira Minkis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benedict Ho, BA

Role: CONTACT

beh2024@med.cornell.edu

646-962-6647

Kira Minkis, MD PhD

Role: CONTACT

kim9036@med.cornel.edu

646-962-6647

Facility Contacts

Kira Minkis, MD, PhD

Role: primary

kim9036@med.cornell.edu

(646) 962-0033

Benedict Ho, BA

Role: backup

beh2024@med.cornell.edu

9175025230

Other Identifiers

22-10025244-1

Identifier Type: -

Identifier Source: org_study_id