Ethyl Chloride Spray to Reduce Pain From Local Anesthesia During Mohs Micrographic Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- VAS pain scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Gebauer's Ethyl Chloride Topical Spray (Drug)
结局指标
主要结局
VAS pain scores
时间窗: 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?"
时间窗: 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?".
次要结局
未报告次要终点