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临床试验/NCT00880529
NCT00880529终止4 期

Does Continuous Subcutaneous Paravertebral Infusion of Bupivicaine With the ON-Q Pain Relief System vs. Standard IV Pain Management Decrease Ventilator Dependence in Trauma Patients With Multiple Rib Fractures

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
2
试验地点
1
主要终点
Time from weaning process initiation to discontinuation of ventilatory support

研究概览

简要总结

The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief System for pain management of multiple rib fractures will require fewer ventilator days, and will need less IV pain medicine to control their pain, and as a result have improved respiratory function during their recovery.

The standard of care for providing pain relief for rib fractures is to use an opioid drug that is injected into the vein but also has side effects. Increased doses can lead to over sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is delivered from a thin tube approximately 10 inches long is tunneled under the skin along the back and parallel to the spine. The medication is stored in an elastic pump which delivers a slow continuous drip of medication from multiple holes in the tubing. Subjects will be randomized to either standard intravenous opioid pain management or the ON-Q pain relief device with supplemental opioid medication if needed. The device will remain in use until the subjects are able to breathe without the ventilator.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age
  • 3 or more rib fractures
  • Intubated ready for weaning from ventilator support
  • FI02 < 50%
  • Peep < 10cm H2O

排除标准

  • < 18 years of age
  • Unable to communicate pain status
  • Allergy to local anesthetics
  • Coagulopathy
  • Skin lesions or abnormalities from previous injury or surgery
  • < 3 rib fractures

研究组 & 干预措施

ON-Q

Experimental

Subcutaneous bupivicaine administration and IV opioid medication if necessary

干预措施: ON-Q bupivicaine administration (Device)

IV opioids alone

Active Comparator

Standard therapy with IV opioid administration

干预措施: IV opioid administration (Drug)

结局指标

主要结局

Time from weaning process initiation to discontinuation of ventilatory support

时间窗: Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed

次要结局

  • total dose of narcotics given will be identified and reported as mcg or mg each 24 hour period that ON-Q pain pump is being used.(each 24 hours)

研究者

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

Ashley Shapiro

Principal investigator

The Cooper Health System

研究点 (1)

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