Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- postoperative pain scores change on the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.
详细描述
The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients
- All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman having caesarean section for the first time
- •Woman, who have had no previous lower abdominal surgery
- •Woman who can give informed consent
排除标准
- •Diabetes Mellitus (This does not include gestational diabetes)
- •Infection
- •Regular treatment with immunosuppressives
- •Alcohol or drug abuse
- •Age under 18 years old
- •Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
- •BMI over 35
结局指标
主要结局
postoperative pain scores change on the Visual Analog Scale (VAS)
时间窗: 1, 3 and 7 days
the difference in pain scores between two groups 1, 3 and 7 days postoperatively. Pain is registered by a score on a vas-scale from 0-10.Changes on VAS scale reported.
次要结局
- postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus(7 days postoperatively)
- postoperative pain scores change on the Visual Analog Scale (VAS)(1and 3 months postoperatively)
- postoperative sensory loss change on skin incision scar(1and 3 months postoperatively)
研究者
fatma yazıcı yılmaz
medical doctor
Sisli Hamidiye Etfal Training and Research Hospital