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

NCT06920381 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2251013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Keywords

Mohs micrographic surgery; Ethyl Chloride Spray

Outcome Measures

Primary Outcomes (2)

• VAS pain scores

  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.

  During the MMS procedure

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

  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?".

  Immediately after the MMS procedure

Study Arms (2)

Ethyl Chloride Spray

EXPERIMENTAL

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.

Drug: Gebauer's Ethyl Chloride Topical Spray

Control

NO INTERVENTION

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.

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.

Ethyl Chloride Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Dermatology

Sacramento, California, 95816, United States

RECRUITING

Related Publications (8)

• Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.

  PMID: 7636457 RESULT

• Abbasi H, Ali F, Aslam H, Khan MS, Waqas M, Lal A. Cryoanesthesia with ethyl chloride spray versus 5% lidocaine gel in alleviating oral local anesthetic injection pain for buccal anaesthesia: A randomized clinical (controlled) trial. J Dent Res Dent Clin Dent Prospects. 2023 Winter;17(1):40-46. doi: 10.34172/joddd.2023.37041. Epub 2023 Apr 3.

  PMID: 37650023 RESULT

• Irkoren S, Ozkan HS, Karaca H. A Clinical Comparison of EMLA Cream and Ethyl Chloride Spray Application for Pain Relief of Forehead Botulinum Toxin Injection. Ann Plast Surg. 2015 Sep;75(3):272-4. doi: 10.1097/SAP.0000000000000121.

  PMID: 25536197 RESULT

• Flynn A, Barry R. Use of Ethyl Chloride in Dermatology Minor Surgery. Dermatol Surg. 2016 Mar;42(3):433-4. doi: 10.1097/DSS.0000000000000623. No abstract available.

  PMID: 26849089 RESULT

• Beroukhim K, Goldberg LH, Tarantino IS, Kimyai-Asadi A. The effect of intraoperative pain on patient satisfaction during Mohs micrographic surgery. J Am Acad Dermatol. 2022 Oct;87(4):848-849. doi: 10.1016/j.jaad.2021.10.025. Epub 2021 Oct 22. No abstract available.

  PMID: 34695530 RESULT

• Henke J, Immaneni S, Blalock T. Measuring pain and anxiety surrounding local anesthesia in Mohs micrographic surgery: A continuous and repeated-measure pilot study. J Am Acad Dermatol. 2023 Dec;89(6):1298-1300. doi: 10.1016/j.jaad.2023.08.039. Epub 2023 Aug 23. No abstract available.

  PMID: 37625700 RESULT

• Cooper DD, Seupaul RA. Does buffered lidocaine decrease the pain of local infiltration? Ann Emerg Med. 2012 Apr;59(4):281-2. doi: 10.1016/j.annemergmed.2011.05.025. Epub 2011 Aug 6. No abstract available.

  PMID: 21820761 RESULT

• Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.

  PMID: 26156269 RESULT

Central Study Contacts

Salsala Nasim, BS

CONTACT

916-551-2636; sanasim@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This 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).

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1)