Split Face Study of the Duration of Local Anesthetics - Fourth Arm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.5 ml lidocaine + epinephrine 1:100,000, 1.0 ml lidocaine + epinephrine 1:100,000.
- Who it may be relevant to
- Registry conditions: Anesthesia, Local. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery - Fourth Arm
Overview
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
Interventions
- 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
Primary outcome measures
- Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments [Time frame: Up to 4 hours.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT06694714 · 22-10025244-1