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

ConditionAnesthesia, Local

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female ≥ 18 years of age

Normal skin sensation at both nasal ala assessed by pinprick

Ability to provide informed consent

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

35 Participants

are divided into 2 treatment groups

Group A: 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrineExperimental treatment 2 interventions

Group B: 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

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.

Time frame

Up to 4 hours.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Source ClinicalTrials.gov

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