A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Compared rescued dose of morphine injection
研究概览
简要总结
This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection
详细描述
Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017
- •Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
- •Pregnant women more than 20 years of age
- •Gestational age more than 37 week
- •Cesarean section under regional or general anesthesia
- •Ability to communicating, writing and reading Thai language
排除标准
- •Inability to communicating or writing or reading Thai language
- •Contraindicated to bupivacaine or diclofenac or morphine
- •Pregnant women with emergency conditions
- •Have one or more complication of pregnancy
- •Intraoperative arrhythmia
- •Pregnant women less than 20 years of age
- •Regional anesthesia with morphine
研究组 & 干预措施
Group Bupivacaine
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
干预措施: Bupivacaine (Drug)
Group Diclofenac
diclofenac 75 mg intramuscular, 2 hours postoperation
干预措施: Diclofenac (Drug)
结局指标
主要结局
Compared rescued dose of morphine injection
时间窗: Within 24 hours post-operation
Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale
时间窗: 2, 6 and 24 hours post-operation
次要结局
未报告次要终点