Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Laparoscopic Gynecologic Surgery? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain VAS scores at rest and during coughing were recorded postoperatively
研究概览
简要总结
To evaluate the efficacy of lidocaine patch applied around wound in laparoscopic gynecologic surgery in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo.
详细描述
Postoperative pain after gynecologic surgery is a challenging problem associated with increased morbidity and cost. The inflammatory response to surgery plays a crucial rule in inducing postoperative illus. Systemic local anesthetics proved to have anti-inflammatory properties that may be beneficial in preventing ileus added to its analgesic actions. The lidocaine patch evaluated in many types of pain with promising results. The study try to evaluate the patch in perioperative field as a more simple and safe technique than the intravenous route.
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
- Single (Participant)
盲法说明
randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female undergoing elective gynecologic surgery
排除标准
- •known allergy to lidocaine,
- •respiratory or cardiac dysfunction, arrhythmia, treatment with antiarrhythmic drugs,
- •inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •hepatic, renal
- •chronic use of analgesics or corticosteroids
研究组 & 干预措施
lidocaine patches
for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.
干预措施: lidocaine patches (Drug)
IV lidocaine
received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
干预措施: IV lidocaine (Drug)
IV saline infusion
received i.v. saline infusion.
干预措施: IV saline infusion (Drug)
结局指标
主要结局
Pain VAS scores at rest and during coughing were recorded postoperatively
时间窗: 24 hours
To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".
次要结局
未报告次要终点
研究者
hany farouk
A Professor
Aswan University Hospital