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临床试验/NCT02184559
NCT02184559Unknown3 期

Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
试验地点
1
主要终点
Consumption morphinize

研究概览

简要总结

The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.

The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman whose age is 18 years
  • Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
  • Woman ASA I and II
  • Term = 37 LIMITED COMPANIES
  • Woman primipare or not
  • Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol

排除标准

  • Minor Woman
  • Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm > 38.5 ° C)
  • Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
  • The surgical histories of laparotomy
  • The morbid obesity BMI > 35
  • Dysgravidies
  • Woman not being affiliated to the national insurance scheme
  • Woman under legal protection
  • Woman not having signed an informed consent

研究组 & 干预措施

TAP block

Experimental

干预措施: Ropivacaine (Drug)

infiltration continues

Active Comparator

干预措施: The infiltration continues catheter (Device)

结局指标

主要结局

Consumption morphinize

时间窗: 48 hours

the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours

次要结局

  • Analgesic efficiency(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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