The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The pain score
研究概览
简要总结
The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy
详细描述
After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I - II
- •Scheduled open unilateral herniorrhaphy
排除标准
- •body mass index (BMI) < 18.5 or ≥ 35 kg/m2
- •severe renal or hepatic dysfunction
- •allergy to amide-based local anesthetic agents
- •taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)
研究组 & 干预措施
Group L(lidocaine patch)
Attach two lidocaine patches for 12 hours, above and below the incision site.
干预措施: Group L (Drug)
结局指标
主要结局
The pain score
时间窗: 24 hours after the anesthesia finished.
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
次要结局
- The pain score(2 hours after the anesthesia finished.)
- Total amount of cumulative analgesics(24 hours after the anesthesia finished.)
研究者
BON WOOK KOO
associative professor of anesthesiology
Seoul National University Bundang Hospital