Anesthetics, Local
Conditions
Keywords
Anesthesia, Mohs, lidocaine, ropivacaine, bupivacaine
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.
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.
Interventions
0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.
DRUGRopivacaine 0.5% Injectable Solution
0.5 ml Ropivacaine 0.5% Injectable Solution
0.5ml bupivacaine 0.5%
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
75 subjects were recruited from March to July, 2023 at one site.
Participants by arm
| Arm | Count |
|---|---|
| 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) (compared to 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb. | 24 |
| 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) (compared to 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb. | 23 |
| Ropivacaine (vs Lidocaine+Epinephrine) 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) (compared to 0.5ml 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 administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution | 24 |
| Ropivacaine (vs Lidocaine+Epinephrine) 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) (compared to 0.5ml 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 administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution | 23 |
| 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 Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb. | 25 |
| 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 Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb. | 23 |
| Bupivacaine (vs Lidocaine+Epinephrine) 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 bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml 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 administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5% | 25 |
| Bupivacaine (vs Lidocaine+Epinephrine) 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 bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml 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 administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5% | 23 |
| 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 0.5 ml Ropivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution | 26 |
| 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 0.5 ml Ropivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution | 24 |
| Bupivacaine (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 bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5 ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5% | 26 |
| Bupivacaine (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 bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5 ml 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 , until the patient reports return of a sharp sensation upon the pinprick test.
Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5% | 24 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Lidocaine+Epinephrine (vs Ropivacaine) | Ropivacaine (vs Lidocaine+Epinephrine) | Lidocaine+Epinephrine (vs Bupivacaine) | Bupivacaine (vs Lidocaine+Epinephrine) | Ropivacaine (vs Bupivacaine) | Bupivacaine (vs Ropivacaine) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 14 Participants | 19 Participants | 19 Participants | 20 Participants | 20 Participants | 106 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 23 Participants | 23 Participants | 24 Participants | 24 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants | 22 Participants | 22 Participants | 23 Participants | 23 Participants | 134 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 8 Participants | 8 Participants | 10 Participants | 10 Participants | 54 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 17 Participants | 17 Participants | 16 Participants | 16 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Up to 4 hours.
Population: Participants were excluded from analysis if they withdrew from the study (1 participant), did not regain sensation bilaterally before leaving the study site (3 participants), or, if the time to regain sensation could not be accurately determined (1 participant).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine+Epinephrine (vs Ropivacaine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 54.34 Minutes | Standard Deviation 27.48 |
| Ropivacaine (vs Lidocaine+Epinephrine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 49.86 Minutes | Standard Deviation 22.53 |
| Lidocaine+Epinephrine (vs Bupivacaine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 43.13 Minutes | Standard Deviation 22.2 |
| Bupivacaine (vs Lidocaine+Epinephrine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 55.78 Minutes | Standard Deviation 24.62 |
| Ropivacaine (vs Bupivacaine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 52.33 Minutes | Standard Deviation 24.09 |
| Bupivacaine (vs Ropivacaine) | Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments | 46.16 Minutes | Standard Deviation 20.24 |
p-value: 0.9395% CI: [-12.8, 14]t-test, 2 sided
p-value: 0.5495% CI: [-8.3, 15.8]t-test, 2 sided
p-value: 0.695% CI: [-8.7, 15]t-test, 2 sided