Is Lidocaine Patch as Effective as Intravenous Lidocaine in Pain and Illus Reduction After Cesarean Section? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Total dose of opioids received in the first 24 hours following Cesarean
研究概览
简要总结
To evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.
详细描述
The use of lidocaine as a local anesthetic is a common and widely used in practice. Lidocaine patches can be used for localized pain control and can be placed every 24 hours. The use of lidocaine patches in post-operative patients has been reported in one case report in obstetric literature. There is one study that reports decreased immediate postoperative pain when lidocaine patches were placed at laparoscopic port sites following gynecologic surgery as measured by visual analog scale score and the Prince Henry and 5-point verbal rating pain scale . There have been no studies looking at the impact of lidocaine patches in obstetric surgical procedures, specifically cesarean sections.
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)
盲法说明
double blind randomized controlled study
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
- •Primary or secondary cesarean delivery
- •Able to consent to research study
排除标准
- •3 or more prior cesarean deliveries
- •History of abdominoplasty
- •History of abdominal hernia repair with mesh
- •Allergy to lidocaine
- •Allergy to adhesives in medical tape
- •Women who received general anesthesia for their cesarean delivery
- •Women with active substance abuse
- •Women methadone or suboxone for a history of opiate abuse
研究组 & 干预措施
lidocaine patch
5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
干预措施: lidocaine patch (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 +Sham patch
received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
干预措施: IV saline infusion +Sham patch (Drug)
结局指标
主要结局
Total dose of opioids received in the first 24 hours following Cesarean
时间窗: 24 hours
The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.
Post-operative pain score at 24 hours post-operatively
时间窗: 24 hours
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
次要结局
- Incidence of complications of lidocaine use(72 hours)
- Return of bowel function(72 hours)
研究者
hany farouk
A Professor
Aswan University Hospital