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

NCT ID: NCT06920381

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gebauer's Ethyl Chloride Topical Spray

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gebauer's Ethyl Chloride Topical Spray

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Davis Dermatology

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Salsala Nasim, BS

Role: CONTACT

916-551-2636

Facility Contacts

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Salsala Nasim, BS

Role: primary

Daniel Eisen, MD

Role: backup

References

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

Reference Type RESULT
PMID: 7636457 (View on PubMed)

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.

Reference Type RESULT
PMID: 37650023 (View on PubMed)

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.

Reference Type RESULT
PMID: 25536197 (View on PubMed)

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.

Reference Type RESULT
PMID: 26849089 (View on PubMed)

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.

Reference Type RESULT
PMID: 34695530 (View on PubMed)

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.

Reference Type RESULT
PMID: 37625700 (View on PubMed)

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.

Reference Type RESULT
PMID: 21820761 (View on PubMed)

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.

Reference Type RESULT
PMID: 26156269 (View on PubMed)

Other Identifiers

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2251013

Identifier Type: -

Identifier Source: org_study_id

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