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Completed

NCT Number: NCT06920381

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UC Davis Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients scheduled for MMS with Dr. Daniel Eisen at UC Davis Health Department of Dermatology (3301 C St #1300-1400, Sacramento, CA 95816)
  • Pre-op tumor size at least 1.5 cm (measured on day of procedure)

Exclusion criteria

  • Skin disorders related to cold temperatures (i.e. cryoglobulinemia)
  • Anxiolytic medication within past 4 hours
  • Treatment sites around the eyes
  • Pre-op tumor size smaller than 1.5 cm (measured on day of procedure)

Treatment and study plan

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.

Primary outcomes

  1. VAS pain scores

    Time frame: During the MMS procedure

    The primary outcome measure will be the Visual Analog Scale (VAS) pain scores recorded at the time of the initial injection and during the infiltration of anesthetic for each treatment side. Patients will self-report their VAS score from a scale of 0-10. VAS scores will be sorted into 4 categories: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain.

  2. Subject response to "do you prefer precooling with ethyl chloride spray in future Mohs surgery cases?"

    Time frame: Immediately after the MMS procedure

    Secondary outcome measure will be study subject's responses to the question: "do you prefer precooling with ethyl chloride spray in future Mohs surgery cases?".

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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