NCT01900626终止不适用
Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pain Scores With Activity
研究概览
简要总结
This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery via a posterior approach for AIS
- •Children ages 11-18
- •ASA physical status 1-2
- •Informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age)
- •Planned correction of at least 8 vertebral levels
排除标准
- •Patient refusal to participate
- •Patients on chronic narcotic medication
- •Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam)
- •Coagulopathy
- •Pre-existing neurological deficit
- •Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment
研究组 & 干预措施
single epidural catheter
Active Comparator
干预措施: epidural catheter (Drug)
double epidural catheter
Active Comparator
干预措施: epidural catheter (Drug)
结局指标
主要结局
Pain Scores With Activity
时间窗: 72 hours
The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome
次要结局
- Pain Scores at Rest(72 hours)
- Opioid Usage(72 hours)
- Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire(3 months)
- Functional Outcomes: The Owestry Disability Index(ODI)(3 months)
- Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score(3 months)
研究者
研究点 (1)
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