Treatment Prior to Injection and Biopsy of the Vulva
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Post-injection Pain Score
研究概览
简要总结
This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.
详细描述
To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area.
Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues.
The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Undergoing vulva biopsy during clinic visit
- •Willing and able to comply with study protocol
- •Able to understand and provide informed consent
排除标准
- •Inability to provide informed consent
结局指标
主要结局
Post-injection Pain Score
时间窗: Immediately after local anesthetic injection
Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain.
次要结局
- Post-biopsy pain score(Immediately after procedure.)
- Post-procedure pain control score(Immediately after procedure)
- Post-procedure satisfaction score(Immediately after procedure)
- Post-procedure anxiety score(Immediately after procedure)
研究者
Kirby Woodall
Resident Physician
University of Missouri-Columbia