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临床试验/NCT00413582
NCT00413582已完成不适用

Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2006年10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
发起方
入组人数
110
试验地点
1
主要终点
Length of Hospitalization

研究概览

简要总结

The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair.

The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort.

The primary outcome variable is length of hospitalization after the intervention.

详细描述

This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study.

Power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. The primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. One group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. The other groups will receive patient controlled intravenous systemic analgesia (PCA).

Both groups will have the same management algorithm. All data will be analyzed on intention-to-treat basis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients undergoing a pectus excavatum repair with bar placement.

排除标准

  • Open repair
  • Re-Do operation
  • Known allergy to a pain medication in the protocol
  • Existing contraindications to epidural catheter placement
  • Requirement for 2 bars to be placed (rare)
  • Inadequate baseline cognitive function to understand/respond to VAS questionnaire

研究组 & 干预措施

1

Active Comparator

Epidural analgesia

干预措施: Epidural Analgesia (Drug)

2

Experimental

IV narcotic analgesia

干预措施: Patient-Controlled IV Analgesia (Drug)

结局指标

主要结局

Length of Hospitalization

时间窗: 1 week

次要结局

  • Time in the Operating Room(1 week)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn St. Peter

MD

Children's Mercy Hospital Kansas City

研究点 (1)

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