The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Pain Outcome: Visual Analog Scale
研究概览
简要总结
Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.
Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.
The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>12 years old presenting with an indication for intralesional steroid injection
排除标准
- •Unconsentable
- •Not a candidate for corticosteroid injection
- •Contraindication to lidocaine
研究组 & 干预措施
Corticosteroid with lidocaine
This arm will include an injection mixture of corticosteroid and lidocaine
干预措施: Corticosteroid with lidocaine (Drug)
Corticosteroid with normal saline
This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.
干预措施: Corticosteroid with normal saline (Drug)
结局指标
主要结局
Pain Outcome: Visual Analog Scale
时间窗: Assessed 1 minute after the injection (in clinic)
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
次要结局
未报告次要终点
研究者
Brian Drolet
Assistant Professor
Vanderbilt University Medical Center