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

University of California (UC) Davis

Status and phase: Begins enrollment in 1 month; Early Phase 1

Conditions: Surgery

Treatments: Drug: Gebauer's Ethyl Chloride Topical Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06920381

2251013

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ethyl Chloride Spray

Experimental group

Description:

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.

Treatment:

Drug: Gebauer's Ethyl Chloride Topical Spray

Control

No Intervention group

Description:

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.