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临床试验/NCT02290054
NCT02290054已完成不适用

Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery

Hopital Foch1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
53
试验地点
1
主要终点
bladder catheterization

研究概览

简要总结

Urinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •patients scheduled to a lung surgical procedure and thoracic epidural analgesia

排除标准

  • •Abnormalities of the external ear
  • •Dialysis or end stage renal failure
  • •Abnormal urinary tract
  • •Incapacity to self assessment of comfort and anxiety,
  • •Contra-indication to total intravenous anesthesia

研究组 & 干预措施

Control

Sham Comparator

A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

干预措施: Intra-venous anesthesia (Procedure)

Control

Sham Comparator

A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

干预措施: Control (Procedure)

Treated

Experimental

A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Auriculotherapy is performed while the patient is sleeping but before thoracic incision.

Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

干预措施: Treated (Procedure)

Treated

Experimental

A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Auriculotherapy is performed while the patient is sleeping but before thoracic incision.

Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

干预措施: Intra-venous anesthesia (Procedure)

结局指标

主要结局

bladder catheterization

时间窗: 24 hours

Requirement of bladder catheterization during the day and the first night following surgery

次要结局

  • Anxiety(24 hours)
  • Comfort(24 hours)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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