NCT03652116已完成2 期
Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postoperative wound pain: VAS
研究概览
简要总结
The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mode of delivery: Cesarean section.
- •Gestational age: 37-40 weeks.
- •Type of anaesthesia: Spinal anaesthesia.
- •No past history of any medical disorder or other medical complications during pregnancy.
排除标准
- •Women with known hypersensitivity to bupivacaine or pethidine.
- •Women delivered vaginally.
- •Women delivered under general anaesthesia.
- •Women with known neurological or psychological disease.
研究组 & 干预措施
Bupivacaine Group
Active Comparator
Patients delivered by cesarean section followed by wound infiltration by bupivacaine.
干预措施: Wound infiltration by Bupivacaine (Drug)
Pethidine Group
Active Comparator
Patients delivered by cesarean section followed by wound infiltration by pethidine.
干预措施: Wound infiltration by Pethidine (Drug)
结局指标
主要结局
Postoperative wound pain: VAS
时间窗: first 24 hours postoperatively
Postoperative wound pain will be assessed using visual analogous scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Mean values will be calculated and compared between the three groups
次要结局
- Total dose of opioid drugs needed(first 24 hours postoperatively)
- Incidence of nausea and vomiting(first 24 hours postoperatively)
- Incidence of urine retention(first 24 hours postoperatively)
- Incidence of hypotension(first 24 hours postoperatively)
研究者
Sarah Safwat
Lecturer in Obstetrics and Gynecology
Ain Shams University
研究点 (1)
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