The Efficacy and Safety of Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation Before Surgery: a Multicenter, Randomized, Double -Blind, Placebo-controled and Parallel-group Designed Clinical Trail
试验速览
- 阶段
- 2 期
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
研究概览
简要总结
Venipuncture and intravenous cannulation are the most common painful procedures, especially for the penitents who must receive large diameter venous catheter before surgery. In present study we would evaluate the safety and validity of lidocaine patches releasing such pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who want to participate present study and sign the informed consent form
- •Age from 18 to 65 years old
- •Patients who need intravenous cannulation before surgery
- •ASA class I-II and selected patients
排除标准
- •Allergic to lidocaine or any other amide local anesthetics or any other medicine
- •Allergic skin(allergic to past agent or other topical used medicine)
- •Skin injured or inflection exist in the local site to patch
- •Sensation disturbed in any limb
- •Severe liver and kidney original disease:blood Aspertate aminotransferase and Alanine transaminase increased 1.5 times more than normal concentration; blood creatinine is higher than the normal range.
- •Hemoglobin <80g/L
- •ECG is significantly abnormal
- •pregnant or possible pregnant or breastfeeding woman
- •Patient who has consciousness disturbance can not make credible dialog with investigator.
- •Those who are using other medicine may affect the evaluation of present patch
- •Those who have participated in other clinical trail in the past three months
- •Those excluded by investigator believed other reasons.
研究组 & 干预措施
Lidocaine Patches
干预措施: Lidocaine Patches (Drug)
结局指标
主要结局
The efficiency of lidocaine patches for attenuating the pain of venipuncture intravenous cannulation before surgery
时间窗: Two minters after intravenous cannulation
VAS score will be evaluated two minters after intravenous cannulation in both group with lidocaine patches or not.
Skin response after intravenous cannulation
时间窗: Thirty minters after intravenous cannulation
Local skin response to the lidocaine patches will be evaluated thirty minters after intravenous cannulation
次要结局
未报告次要终点