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临床试验/NCT03002909
NCT03002909已完成不适用

Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy

Assiut University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
changes in the level of inflammatory cytokines in pg /ml

研究概览

简要总结

the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III patients
  • aged 18-60 yr
  • undergo open abdominal cancer surgery

排除标准

  • general contraindications for epidural analgesia,
  • recent history (8 weeks) of, chemotherapy or radiation,
  • chronic opioid use

研究组 & 干预措施

epidural group

Active Comparator

an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. .

干预措施: epidural catheter (Device)

preperitoneal group

Active Comparator

preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.

干预措施: preperitoneal catheter (Device)

结局指标

主要结局

changes in the level of inflammatory cytokines in pg /ml

时间窗: 24 hours

Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines

次要结局

  • patient satisfaction(24 hours)
  • Visual Analog Scale at rest and on coughing(24 hours)
  • opioid side-effects(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Adel El sherif,MD

lecturer of anesthesia ,icu and pain management

Assiut University

研究点 (2)

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