Split Face Study of the Duration of Local Anesthetics

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05767749

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthetics, Local	Drug: lidocaine + epinephrine 1:100,000 Drug: Ropivacaine 0.2% Injectable Solution Drug: Bupivacaine 0.5% Injectable Solution	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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) 0.2% 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 0.2% Injectable Solution 0.5 ml Ropivacaine 0.2% Injectable Solution Other Names: Naropin
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: 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) 0.2% 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: Ropivacaine 0.2% Injectable Solution 0.5 ml Ropivacaine 0.2% Injectable Solution Other Names: Naropin Drug: Bupivacaine 0.5% Injectable Solution 0.5ml bupivacaine 0.5% Other Names: Marcaine

Arm

Intervention/Treatment

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) 0.2% 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 0.2% Injectable Solution

0.5 ml Ropivacaine 0.2% Injectable Solution

Other Names:

Naropin

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: 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) 0.2% 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: Ropivacaine 0.2% Injectable Solution

0.5 ml Ropivacaine 0.2% Injectable Solution

Other Names:

Naropin

Drug: Bupivacaine 0.5% Injectable Solution

0.5ml bupivacaine 0.5%

Other Names:

Marcaine

Outcome Measures

Primary Outcome Measures

Time to Return to Baseline Sensation, as determined by binary outcomes (yes/no) in 15 minute increments [Up to 4 hours.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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