Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair
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
- 否
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
Epidural analgesia
干预措施: Epidural Analgesia (Drug)
2
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
Shawn St. Peter
MD
Children's Mercy Hospital Kansas City
