Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Cesarean section is the most performed abdominal surgery in women, worldwide. The World Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery. However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in hospitals and private clinics.
The most used technique of cesarean section is the known as Pfannenstiel or Classical technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive technique.
Several studies have show that the minimally invasive technique is faster and promotes lower costs and less intraoperative bleeding. There is no current evidence that this technique is less painful.
This study aims to compare the postoperative pain in both techniques,by means of two pain scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the McGill Scale.
详细描述
- STUDY
Primary, clinical, prospective, randomized, double blind with, controlled, two parallel groups interventional and analytical. 2. MATERIAL
A-CALCULATION OF SAMPLE SIZE
Were used to calculate the size of the sample study data Antalon et al. (2001), who also compared the two techniques of caesarean section, and the Student's t-test was used bi flow. Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and significant a difference of two points, the calculated number of patients per group was 15, with a significance level of 5% and power of 95 test %.
C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous patients who are undergoing cesarean section
排除标准
- •Previous pelvic and/or abdominal surgery ;
- •Emergency cesarean section, due to placenta previa, fetal distress, cord prolapse or other obstetric emergencies;
- •Pregnancies below 36 weeks.
结局指标
主要结局
Pain
时间窗: Postoperative 24 hours
pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative
次要结局
- time spent in two different techniques for cesarean(1 hour)
研究者
Ivanildo Archangelo Junior
MD
Universidade do Vale do Sapucai