Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
研究概览
简要总结
Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.
详细描述
Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cesarean section with regional anesthesia
- •singleton
- •pfannenstiel incision
排除标准
- •cesarean section with general anesthesia
- •maternal liver or kidney disease
- •allergy to Bupivacaine
- •allergy to Adrenalin
- •intrauterine fetal death
- •major fetal malformations
研究组 & 干预措施
Intervention
Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.
干预措施: Intervention (Drug)
结局指标
主要结局
Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
时间窗: up to 24 hours
Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.
次要结局
- Length of the cesarean section(up to 24 hours)
- Need for opioids(up to 4 days)
- Length of stay from surgery to discharge(up to 4 days)
- Time from surgery to mobility(up to 48 hours)
- Time from surgery to breastfeeding(up to 4 days)
- surgical site infection(up to 42 days)
- Surgical site hematoma(4 days)
- questionnaire(up to 4 days)