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0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with 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

* Male or female ≥ 18 years of age

* Normal skin sensation at both nasal ala assessed by pinprick

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 hours.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Drug Has Already Been Approved

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

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.

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 / 3Eligibility criteria met