Split Face Study of the Duration of Local Anesthetics - Fourth Arm

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06694714
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anesthesia, Local

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 0.5 ml lidocaine + epinephrine 1:100,000 — DRUG
    0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb
  • 1.0 ml lidocaine + epinephrine 1:100,000 — DRUG
    1.0 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb

Study Details

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.

Key Dates

Start date
Jan 21, 2025
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.5 ml Lidocaine with epinephrine vs. 1.0 ml Lidocaine with epinephrine
    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.
  • Experimental: 1.0 ml Lidocaine with epinephrine vs 0.5 ml Lidocaine with epinephrine
    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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10021
Kira Minkis, MD, PhD
[email protected]
(646) 962-0033
Benedict Ho, BA
[email protected]
9175025230
Kira Minkis, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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