Anesthesia, LocalPhase 4NCT06694714
Split Face Study of the Duration of Local Anesthetics - Fourth Arm
A Phase 4 study testing 0.5 ml lidocaine + epinephrine 1:100,000 and 1.0 ml lidocaine + epinephrine 1:100,000 in people with Anesthesia, Local, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- 0.5 ml lidocaine + epinephrine 1:100,000 and 1.0 ml lidocaine + epinephrine 1:100,000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 1 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Normal skin sensation at both nasal ala assessed by pinprick
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Kira Minkis, MD, PhD, (646) 962-0033, kim9036@med.cornell.edu
Benedict Ho, BA, 9175025230, beh2024@med.cornell.edu
About this study
Official title: Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery - Fourth Arm
This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.
Read the detailed description
The investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. The investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. Specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. The investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. The investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face.
This study record uses the same protocol document of a previous study under Clinical Trials record NCT05767749, but documents a fourth arm for which data will be analyzed separately from data in NCT05767749
- Conditions
- Anesthesia, Local
- Being tested
- 0.5 ml lidocaine + epinephrine 1:100,000, 1.0 ml lidocaine + epinephrine 1:100,000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 ml lidocaine + epinephrine 1:100,000Drug
0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb
1.0 ml lidocaine + epinephrine 1:100,000Drug
1.0 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb
| Study group | Role | What they receive |
|---|---|---|
| 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine | Experimental | Each side 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 1.0 ml 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 volume 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. Receives: Drug: 0.5 ml lidocaine + epinephrine 1:100,000; Drug: 1.0 ml lidocaine + epinephrine 1:100,000 |
| 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine | Experimental | Each side 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 1.0ml 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 0.5 ml 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 volume 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. Receives: Drug: 0.5 ml lidocaine + epinephrine 1:100,000; Drug: 1.0 ml lidocaine + epinephrine 1:100,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start21 Jan 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kira Minkis, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694714
- Sponsor's protocol ID
- 22-10025244-1
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery - Fourth Arm
- ClinicalTrials.gov ID
- NCT06694714
- Acronym / sponsor ID
- 22-10025244-1
- Conditions
- Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.
Detailed description
The investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. The investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. Specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. The investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. The investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face.
This study record uses the same protocol document of a previous study under Clinical Trials record NCT05767749, but documents a fourth arm for which data will be analyzed separately from data in NCT05767749
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine | Experimental | Drug: 0.5 ml lidocaine + epinephrine 1:100,000, Drug: 1.0 ml lidocaine + epinephrine 1:100,000Each side 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 1.0 ml 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 volume 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. |
| 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine | Experimental | Drug: 0.5 ml lidocaine + epinephrine 1:100,000, Drug: 1.0 ml lidocaine + epinephrine 1:100,000Each side 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 1.0ml 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 0.5 ml 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 volume 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age
- Normal skin sensation at both nasal ala assessed by pinprick
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 ml lidocaine + epinephrine 1:100,0000.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb | Drug | 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine, 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine |
| 1.0 ml lidocaine + epinephrine 1:100,0001.0 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb | Drug | 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine, 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine |
Primary outcome
Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kira Minkis, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5 ml lidocaine + epinephrine 1:100,000 and 1.0 ml lidocaine + epinephrine 1:100,000 in people with Anesthesia, Local, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedict Ho, BA (646-962-6647, beh2024@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments (time frame: Up to 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.