Split Face Study of the Duration of Local Anesthetics

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthetics, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

0.5mL of local anesthetic will be injected into the skin of each participant by the one dermatologic surgeon (PI of the study, Dr. Kira Minkis, KM). Dr. Minkis will be unblinded to the laterality of the anesthetics and will not be involved in further assessments.

Study Groups

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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.

Group Type EXPERIMENTAL

lidocaine + epinephrine 1:100,000

Intervention Type DRUG

0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

0.5 ml Ropivacaine 0.5% Injectable Solution

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.

Group Type EXPERIMENTAL

lidocaine + epinephrine 1:100,000

Intervention Type DRUG

0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.

Bupivacaine 0.5% Injectable Solution

Intervention Type DRUG

0.5ml bupivacaine 0.5%

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.

Group Type EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

0.5 ml Ropivacaine 0.5% Injectable Solution

Bupivacaine 0.5% Injectable Solution

Intervention Type DRUG

0.5ml bupivacaine 0.5%

Interventions

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lidocaine + epinephrine 1:100,000

0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.

Intervention Type DRUG

Ropivacaine 0.5% Injectable Solution

0.5 ml Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

Bupivacaine 0.5% Injectable Solution

0.5ml bupivacaine 0.5%

Intervention Type DRUG

Other Intervention Names

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Xylocaine + epinephrine 1:100,000 Naropin Marcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes