Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 156
- 主要终点
- Postoperative pain: 4 point verbal rating scale (VRS)
研究概览
简要总结
The aim of this study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.
详细描述
In recent years, Cesarean deliveries have increased dramatically worldwide. In Egypt, 52% of women give birth by Cesarean Section according to the 2014 Demographic and Health survey. Despite the rising incidence of Cesarean section, controversy about the optimal surgical method of Cesarean section still remains. Obstetricians use a variety of surgical techniques to reduce post-operative adhesions after Cesarean section, such as parietal peritoneal closure and rectal muscle approximation. They believe that adhesions may result from exposure of an opened intraperitoneal cavity to the subfascial space which can be prevented by approximating the rectus muscle or closing the parietal peritoneum. In addition, rectus muscle approximation may be considered to reduce the risk of persistent rectus muscle diastasis. However, different studies showed a controversy and inconsistency in the practice of rectus muscle re-approximation among surgeons. Some obstetricians agree that the rectus muscles can regain their right anatomic position by themselves and that suturing them together does not add any benefit. Even though, one of their main concern against rectus muscle approximation is its potential association with increased post operative pain, hence the importance of this prospective randomized controlled study. The aim of the investigator's study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Primigravida
- •Single pregnancy
- •Term at >37 weeks
- •Maternal age between 18 and 35 yrs
- •Spinal anaesthesia.
- •No other medical diseases.
排除标准
- •• prior laparotomy
- •vertical skin incision
- •chronic analgesia use
- •allergy to opioid or nonsteroidal anti-inflammatory drugs
- •body mass index more than or equal to 40.
研究组 & 干预措施
Rectus muscle reapproximation group
Rectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures
干预措施: Rectus muscle reapproximation during CS (Procedure)
Rectus muscle non reapproximation group
No rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position
干预措施: Rectus muscle non reapproximation during CS (Procedure)
结局指标
主要结局
Postoperative pain: 4 point verbal rating scale (VRS)
时间窗: 1 week after operation
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale.
次要结局
未报告次要终点
研究者
Abdelraheem Ali
Obstetrician
Assiut University
