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临床试验/NCT03176316
NCT03176316终止4 期

The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus

Loyola University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
53
试验地点
1
主要终点
Time to First Bowel Movement

研究概览

简要总结

Postoperative ileus and opioid induced constipation are well-known post-operative complications. Previously, research has shown that using peripherally acting opioid antagonists can help alleviate the condition. There has not been a prospective study to investigate whether use of peripherally acting opioid antagonists are effective in preventing post-operative ileus in patients having spinal fusion surgeries.

详细描述

Post operative ileus is a well-known complication following spinal fusion surgery. There has been some literature to demonstrate the safety and efficacy of oral naloxone to decrease the time to bowel movements after gastrointestinal surgery, to date, there have been no studies within the spine fusion literature to investigate oral naloxone's effects on the time to bowel movements.

The aim of the present study is to use the previously established protocols and doses established in the gastrointestinal literature to see whether oral naloxone can decrease the time to first bowel movements.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Patients will be included if they are having an in-patient spinal fusion procedure, are 18 years or older, post and post-operative pain control plan includes opioid medications.

排除标准

  • Pregnancy, age < 18, nursing, or documented allergy to naloxone

研究组 & 干预措施

Naloxone

Experimental

1 mg/ml oral solution administered enterally every eight hours for 48 hours

干预措施: Naloxone (Drug)

结局指标

主要结局

Time to First Bowel Movement

时间窗: 1 week

We will monitor the patients' bowel movements and record the time to the first bowel movement in hours

次要结局

未报告次要终点

研究者

发起方
Loyola University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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