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

Weill Cornell Medicine (WCM)

Status and phase: Enrolling; Phase 4

Conditions: Anesthesia, Local

Treatments: Drug: 0.5 ml lidocaine + epinephrine 1:100,000; Drug: 1.0 ml lidocaine + epinephrine 1:100,000

Study type: Interventional

Funder types: Other

Identifiers

NCT06694714

22-10025244-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: 1.0 ml lidocaine + epinephrine 1:100,000

Drug: 0.5 ml lidocaine + epinephrine 1:100,000

1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine

Experimental group

Description:

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.

Treatment:

Drug: 1.0 ml lidocaine + epinephrine 1:100,000

Drug: 0.5 ml lidocaine + epinephrine 1:100,000