The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
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
- 否
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
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