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临床试验/NCT02218190
NCT02218190已完成不适用

A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Recovery of Bowel Function

研究概览

简要总结

The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

详细描述

Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control.

We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis

排除标准

  • pregnant women
  • ischemic heart disease
  • chronic liver or renal disease
  • prior bowel resection
  • presence of colostomy or ileostomy
  • gastroparesis
  • complete bowel obstruction
  • inflammatory bowel disease (ulcerative colitis or Crohn's disease).

研究组 & 干预措施

Alvimopan

Experimental

Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.

干预措施: Alvimopan (Drug)

Placebo - Sugar Pill

Placebo Comparator

Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven

干预措施: Placebo (Drug)

结局指标

主要结局

Recovery of Bowel Function

时间窗: 14 days or until hospital discharge whichever occurs first

To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement.

Length of Hospital Stay

时间窗: 14 days or until hospital discharge whichever occurs first

To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.

次要结局

  • Complications and Adverse Event(14 days or until hospital discharge, which ever occurs first)

研究者

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

Michael Kelly

Assistant Prof. Department of Orthopedic Surgery

Washington University School of Medicine

研究点 (1)

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