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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine + epinephrine vs Ropivacaine | Experimental | 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. |
|
| Lidocaine + epinephrine vs Bupivacaine | Experimental | 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. |
|
| Ropivacaine vs Bupivacaine | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine + epinephrine 1:100,000 | Drug | 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kira Minkis, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
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75 subjects were recruited from March to July, 2023 at one site.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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. |
| FG003 | 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% |
| FG004 | 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 |
| FG005 | 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% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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).
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | Minutes | Up to 4 hours. | nasal Ala | nasal Ala |
|
Patients were monitored for adverse events for the duration of their study visit (1 day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kira Minkis | Weill Cornell Medicine | (646) 962-3376 | kim9036@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2024 | Apr 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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|
| Ropivacaine 0.5% Injectable Solution | Drug | 0.5 ml Ropivacaine 0.5% Injectable Solution |
|
|
| Bupivacaine 0.5% Injectable Solution | Drug | 0.5ml bupivacaine 0.5% |
|
|
| BG001 | 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 |
| BG002 | 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. |
| BG003 | 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% |
| BG004 | 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 |
| BG005 | 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% |
| BG006 | Total | Total of all reporting groups |
| nasal ala |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| OG000 |
| 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. |
| OG001 | 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 |
| OG002 | 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. |
| OG003 | 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% |
| OG004 | 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 |
| OG005 | 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% |
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|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | 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% | 0 | 25 | 0 | 25 | 0 | 25 |
| EG004 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
| EG005 | 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% | 0 | 26 | 0 | 26 | 0 | 26 |
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| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |