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临床试验/NCT02192411
NCT02192411Unknown不适用

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

Midwest Vein Center1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年7月最近更新:
适应症
干预措施

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

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

Active Comparator

50mL 1% lidocaine in 450mL normal saline

干预措施: Lidocaine (Drug)

1/4 dose lidocaine

Experimental

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

发起方
Midwest Vein Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Lindner, MD

Principle Investigator

Midwest Vein Center

研究点 (1)

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