Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; a Double Blinded, Randomized, Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Endovenous laser treatment is a minimally invasive procedure that has been shown to be a safe and effective treatment for varicose veins. Essential to the successful ablation of refluxing veins by endovenous laser treatment is the use of tumescent anesthesia. One of the components of tumescent anesthesia is lidocaine, a commonly used local anesthetic. While lidocaine can be used safely as long as serum concentrations remain low, its use carries the risk of lidocaine toxicity. In order to minimize the risk of lidocaine toxicity it is desirable to use the minimum effective concentration of lidocaine needed to manage pain during a procedure. This study seeks to determine if a ¼ lower concentration of lidocaine in tumescent anesthesia will function as well as the standard dose for pain management in endovenous laser treatments. If we find that this is the case, we will be able to reduce the risk of lidocaine toxicity in patients undergoing endovenous laser treatment, while maintaining their comfort throughout the procedure. This will be achieved through a direct comparison of intra- and post-operative pain for patients randomized to receive either the ¼ tumescent lidocaine concentration or the standard lidocaine concentration.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Large Saphenous Vein treatment
- •16-85 years old, good health
- •Able to understand informed consent
- •Eligible for EVLT determined by physician
排除标准
- •Patients with know lidocaine sensitivity
- •Bleeding disorders
- •Pregnancy
- •Congestive heart failure
- •Liver dysfunction
- •Patient ineligible for EVLT
研究组 & 干预措施
Standard Lidocaine
50mL 1% lidocaine in 450mL normal saline
干预措施: Lidocaine (Drug)
1/4 dose lidocaine
12.5mL 1% lidocaine in 487.5mL normal saline
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Deborah Lindner, MD
Principle Investigator
Midwest Vein Center
