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临床试验/NCT02491385
NCT02491385已完成不适用

Effect of Thoracic Epidural Analgesia on Bowel Function Recovery in Major Upper Abdominal Surgeries

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
gas out time

研究概览

简要总结

The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal surgery.

详细描述

Postoperative ileus (POI) is a prolonged inhibition of coordinated bowel activity after surgery. Half of patients undergoing major abdominal surgery experience POI making it one of the limiting factors for early recovery.

The pathogenesis of POI is multifactorial, and includes neurogenic, inflammatory and pharmacological mechanisms. Thoracic epidural analgesia (TEA) can induce sympathetic block, attenuate inflammatory reaction and limit use of systemic opioids. In addition, sympatholysis induced by TEA can improve microcirculation of bowels and parasympathetic activation can increase gastrointestinal motility.

However, studies comparing TEA and iv-PCA on POI are rare in major upper abdominal surgeries. This study, therefore, compares TEA and iv-PCA in terms of bowel function recovery as a primary endpoint in major upper abdominal surgeries. Secondary endpoints are side effects and hospital stay.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists' (ASA) physical statusⅠ-Ⅲ

排除标准

  • ASA status of Ⅳ, or more
  • Body mass index 30 kg.m2-1 or more
  • Severe renal, hepatic, or neurologic diseases
  • Opioid or systemic analgesic preoperatively

研究组 & 干预措施

TEA

Experimental

thoracic epidural analgesia group

干预措施: thoracic epidural analgesia (Procedure)

iv-PCA

Active Comparator

intravenous patient controlled analgesia group

干预措施: iv-PCA (Drug)

结局指标

主要结局

gas out time

时间窗: from operation to post operative 10 days

次要结局

  • voiding time(from operation to post operative 10 days)
  • numeric rating scale for pain(from operation to post operative 3 days)

研究者

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

Hyun Joo Ahn

Associate professor

Samsung Medical Center

研究点 (1)

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