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临床试验/NCT02130739
NCT02130739已完成不适用

Incidence of Transient Horner's Syndrome Following Thoracic Epidural Anesthesia for Mastectomy

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2010年9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
450
试验地点
1
主要终点
Number of Participants with Horner's syndrome

研究概览

简要总结

This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was 1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.

详细描述

Transient Horner's syndrome has been recognized rare complication of epidural anesthesia and the incidence is not exactly well-known in thoracic epidural anesthesia. Therefore, this study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy.

Six hundred thirty three Patients, who scheduled for mastectomy with/without breast reconstruction, were eligible for this prospective observational study from September 2010 to December 2013. Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine 15mL followed by sedation consisting of propofol without muscle relaxation. After the operation, thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h. At 1 hour, 2hour, 1 day, 2 day and 3 day after the operation, postoperative surveillance consisted of the occurrence of symptoms of Horner's syndrome (miosis, ptosis, and hyperemia) were performed by anesthesiologists.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients, who scheduled for mastectomy with/without breast reconstruction

排除标准

  • The patients who had more than one abnormal preoperative clotting parameter either clinical signs of potential bleeding disorders suggested by bruising
  • Petechiae, or ecchymosis, or anatomic or neurologic abnormalities
  • That is, significant scoliosis or kyphosis, radyculopathy or ptosis
  • Unsuccessful catheter placement (impossible to insert a catheter at two vertebral levels)
  • Unsuccessful epidural anesthesia (not checkable sensory block)
  • Dural perforation or intravascular catheterization

研究组 & 干预措施

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

干预措施: thoracic epidural anesthesia (Procedure)

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

干预措施: mastectomy (Procedure)

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

干预措施: Ropivacaine (Drug)

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

干预措施: Propofol (Drug)

thoracic epidural anesthesia

thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy

干预措施: Fentanyl (Drug)

结局指标

主要结局

Number of Participants with Horner's syndrome

时间窗: 3 day after the operation

次要结局

  • Number of Participants with back pain(3 day after the operation)
  • Number of Participants with radiating symptoms(3 day after the operation)
  • Number of Participants with numbness(3 day after the operation)
  • Number of Participants with muscular weakness(3 day after the operation)

研究者

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

Sun Young Park

MD

Soonchunhyang University Hospital

研究点 (1)

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