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Local Anesthetic

Lidocaine + Epinephrine for Local Anesthesia

Phase 4

Waitlist Available

Led By Kira Minkis, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 hours.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to compare the effectiveness of different injectable pain medications used in dermatologic surgery. Researchers will study how the amount of anesthetic used affects how long it lasts in areas with a lot of

Who is the study for?

This trial is for individuals who require local anesthesia, possibly for dermatologic procedures. Specific eligibility criteria are not provided, so it's assumed that participants should be in good health and suitable for receiving local anesthetics.

What is being tested?

The study is testing the duration of pain relief from two different volumes of lidocaine mixed with epinephrine (0.5 ml and 1.0 ml) at sites with a lot of blood vessels to see if more anesthetic means longer pain relief.

What are the potential side effects?

Possible side effects may include temporary redness, swelling at the injection site, increased heart rate due to epinephrine, minor bruising or bleeding, and rarely allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking MAOI or certain types of antidepressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 hours. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrineExperimental Treatment2 Interventions

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 II: 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrineExperimental Treatment2 Interventions

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.

0 / 1Eligibility criteria met