Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Surgery, Mohs micrographic surgery, Ethyl Chloride Spray, Ethyl Chloride, Gebauer's Ethyl Chloride Topical Spray

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06920381
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated