SurgeryEarly Phase 1NCT06920381
Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery
A Early Phase 1 study testing Gebauer's Ethyl Chloride Topical Spray in people with Surgery, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Gebauer's Ethyl Chloride Topical Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 5 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery: A Randomized Clinical Trial
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
- Being tested
- Gebauer's Ethyl Chloride Topical Spray
- Keywords
- Mohs micrographic surgery, Ethyl Chloride Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gebauer's Ethyl Chloride Topical SprayDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?".
Measured: Immediately after the MMS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jun 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920381
- Sponsor's protocol ID
- 2251013
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
PubMed 7636457Abbasi 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.
PubMed 37650023Irkoren 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.
PubMed 25536197Flynn 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.
PubMed 26849089Beroukhim 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.
PubMed 34695530Henke 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.
PubMed 37625700Cooper 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.
PubMed 21820761Shilpapriya 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.
PubMed 26156269
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06920381
- Acronym / sponsor ID
- 2251013
- Conditions
- Surgery
- Keywords
- Mohs micrographic surgery, Ethyl Chloride Spray
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ethyl Chloride Spray | Experimental | Drug: Gebauer's Ethyl Chloride Topical SprayPrior 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gebauer's Ethyl Chloride Topical SprayPrior 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. | Drug | Ethyl Chloride Spray |
Primary outcome
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.
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?".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Results publication: PubMed 7636457Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
- Results publication: PubMed 37650023Abbasi 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.
- Results publication: PubMed 25536197Irkoren 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.
- Results publication: PubMed 26849089Flynn 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.
- Results publication: PubMed 34695530Beroukhim 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.
- Results publication: PubMed 37625700Henke 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.
- Results publication: PubMed 21820761Cooper 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.
- Results publication: PubMed 26156269Shilpapriya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gebauer's Ethyl Chloride Topical Spray in people with Surgery, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain scores (time frame: During the MMS procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920381, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.