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临床试验/NCT02063438
NCT02063438已完成不适用

Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
2
主要终点
Severity of postoperative pain in the perioperative period.

研究概览

简要总结

The purpose of this study is to examine pain associated with thoracotomy (incision made during surgery to obtain access to your thoracic cavity) and how the closure technique may influence postoperative pain. Two types of routinely selected thoracotomy closure techniques will be examined; pericostal and intracostal sutures. The investigators hypothesize that intracostal sutures will result in less postoperative and chronic pain as a result of less compression of the intercostal nerve.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing an elective procedure that will include a thoracotomy.
  • All patients will undergo epidural catheter placement.

排除标准

  • Previous thoracotomy on the operative side.
  • Previous history of chronic chest pain.
  • Previous history of thoracic trauma on the operative side.
  • Less than 18 years of age
  • Inability to provide informed consent or to complete testing or data collection
  • Need for a chest wall resection
  • Patients requiring other incisions in addition to a thoracotomy (i.e., Laparotomy, sternotomy

结局指标

主要结局

Severity of postoperative pain in the perioperative period.

时间窗: 2 weeks following surgery

Intensity and incidence of chronic post-thoracotomy pain

时间窗: 6 months follwong surgery

次要结局

  • Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique(6 months following surgery)
  • Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique(6 months following surgery)

研究者

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

Jules Lin

Assistant Professor; Surgical Director, Lung Transplant

University of Michigan

研究点 (2)

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