Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06920381
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gebauer's Ethyl Chloride Topical Spray — DRUG
    Prior to injection of lidocaine, the investigator will apply ethyl chloride spray, Gebauer's Ethyl Chloride Topical Spray, continuously for 4 to 10 seconds until the skin turns white. This application will be done from a distance of 8 to 18 cm (3 to 7 inches) to the right side of the tumor lesion.

Study Details

Fear of needles is a well-documented issue that affects many patients. This fear may cause significant anxiety in various medical situations, including in the dermatology office 1. If not properly managed, needle phobia can persist, affecting a patient's experience during each visit. This effect may compound and lead to avoidance behaviors that can delay necessary treatments 2. This issue is particularly relevant in a Mohs micrographic surgery (MMS) clinic where each patient experiences several painful needle injections before the day is over. Ethyl chloride is gaining popularity among dermatologists for its routine use in clinical practice due to its anesthetic and antiseptic properties, especially as a pre-injection agent. Research indicates that cryotherapy or pre-cooling the skin before administering a local anesthetic may offer benefits over topical anesthetics, such as enhanced pain relief, quicker onset, and better patient compliance 3,4. However, to our knowledge, no studies have specifically examined the effectiveness of pre-cooling with ethyl chloride prior to Mohs micrographic surgery. To address this gap, we're conducting a trial aimed at evaluating the impact of pre-cooling with ethyl chloride on pain perception in adult patients undergoing Mohs micrographic surgery with local anesthetic injections. The trial is a single-center, split-body study. The split-body design will involve dividing the surgical site into two equal halves, with one half (right side relative to patient) designated as the treatment side (receiving ethyl chloride spray prior to lidocaine injection) and the other as the control side (no ethyl chloride spray prior to injection). During the procedure, the participant will be asked to rate the pain associated with the needle injection AND the pain from infiltration of anesthetic from each side of the wound using the visual analog scale (VAS) scoring system (1 = no pain, 10 = most amount of pain possible). The results of the study will help us better understand how to mitigate pain and anxiety for patients requiring MMS.

Key Dates

Start date
Jun 1, 2025
Status verified
Sep 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ethyl Chloride Spray
    Prior to injection of lidocaine, the investigator will apply ethyl chloride spray, Gebauer's Ethyl Chloride Topical Spray, to the right side of the tumor lesion. This procedure will be performed for all patients participating in the trial.
  • No Intervention: Control
    The investigator will perform no intervention and will continue with the normal standard of care for injecting lidocaine into the left side of the tumor lesion. This procedure will be performed for all patients participating in the trial.

Primary Outcome Measure

VAS pain scores [ Time Frame: During the MMS procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis DermatologySacramentoCalifornia95816
Salsala Nasim, BS
Daniel Eisen, MD

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By research site
UC Davis Dermatology· Sacramento, CA

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