Split Face Study of the Duration of Local Anesthetics

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. This study will compare a short-acting anesthetic, lidocaine with epinephrine, to one of two long-acting anesthetics (ropivacaine or bupivacaine). This study will also directly compare the duration of actions of ropivacaine and bupivacaine. The investigators hypothesize that the duration of anesthesia of short-acting anesthetics will not differ significantly from long-acting anesthetics at a single site and there will not be a significant difference between the two long-acting anesthetics at a single site.

Study Overview

• Status: Completed
• Conditions: Anesthetics, Local
• Intervention / Treatment: Drug: lidocaine + epinephrine 1:100,000; Drug: Bupivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution

Detailed Description

This study will compare the relative durations of local anesthetics within the same subject at a highly vascularized anatomic region of skin, the nasal ala. This study will test and compare the relative durations and efficacy of commonly used long acting (ropivacaine or bupivacaine) and short acting local anesthetics (lidocaine with epinephrine), delivered via local anesthesia. This study will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthetic.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine + epinephrine vs Bupivacaine; Each site 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 lidocaine + epinephrine into one side of the nose (nasal ala) and 0.5ml of Marcaine (bupivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic 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.	Drug: lidocaine + epinephrine 1:100,000; 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.; Other Names: Xylocaine + epinephrine 1:100,000; Drug: Bupivacaine 0.5% Injectable Solution; 0.5ml bupivacaine 0.5%; Other Names: Marcaine
Experimental: Lidocaine + epinephrine vs Ropivacaine; Each site 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 0.5ml of Naropin (ropivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic 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.	Drug: lidocaine + epinephrine 1:100,000; 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.; Other Names: Xylocaine + epinephrine 1:100,000; Drug: Ropivacaine 0.5% Injectable Solution; 0.5 ml Ropivacaine 0.5% Injectable Solution; Other Names: Naropin
Experimental: Ropivacaine vs Bupivacaine; Each site 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 Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) and 0.5ml of Marcaine (bupivacaine) 0.5% into the opposite nasal ala. Laterality of each anesthetic 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.	Drug: Bupivacaine 0.5% Injectable Solution; 0.5ml bupivacaine 0.5%; Other Names: Marcaine; Drug: Ropivacaine 0.5% Injectable Solution; 0.5 ml Ropivacaine 0.5% Injectable Solution; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 hours.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Kira Minkis, MD, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine; Anesthesia; ropivacaine; bupivacaine; Mohs
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Pharmaceutical Solutions; Bupivacaine; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 22-10025244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes