NCT01151943终止4 期
Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- severity of postoperative pain
研究概览
简要总结
Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.
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
- •scheduled cesarean section performed under spinal anesthesia
- •ASA I or II
- •height above 1,55 m
- •singleton pregnancy
排除标准
- •contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)
研究组 & 干预措施
Transversus Abdominis Plane (TAP) Block
Experimental
Patients will receive a bilateral transversus abdominis plane block
干预措施: Transversus Abdominis Plane (TAP) Block (Other)
Incisional Infiltration of Local Anesthetic
Active Comparator
Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
干预措施: Incisional Infiltration of Local Anesthetic (Other)
结局指标
主要结局
severity of postoperative pain
时间窗: 48 postoperative hours
次要结局
- delay before the first rescue dose of morphine(48 postoperative hours)
- morphine requirement(48 postoperative hours)
- complication of each loco-regional technique(end of hospitalisation)
- patient's satisfaction(end of hospitalisation)
- length of hospital stay(end of hospitalisation)
- occurrence of a neuropathic postoperative pain(1 month postoperatively)
研究者
研究点 (1)
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