The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- lowering of pain as measured by visual analogue scores
研究概览
简要总结
Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned cesarean section
- •American Society of Anesthesiologists Class I-II
排除标准
- •Patients refusing to enroll in the study
- •Serious coagulopathy
- •Serious systemic disease
- •Story of allergy to drugs being used in the study
- •Morbid obesity (Body mass index > 30)
研究组 & 干预措施
Tramadol 1
1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
干预措施: Tramadol infusion via wound catheter (Drug)
Tramadol 1
1 mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
干预措施: Levobupivacaine (Drug)
Tramadol 2
2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
干预措施: Tramadol infusion via wound catheter (Drug)
Tramadol 2
2mg/kg tramadol + 0.25% levobupivacaine 4 ml/h infusion
干预措施: Levobupivacaine (Drug)
Levobupivacaine
0.25% levobupivacaine 4ml/h infusion
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
lowering of pain as measured by visual analogue scores
时间窗: forty eight hours after the operation
次要结局
- total additional analgesic consumption(forty eight hours after the operation)
研究者
Perihan Ekmekçi
Associate Professor
Ufuk University