Postoperative Steroids and Recovery After Spine Fusion
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Morphine equivalent pain medication use over the length of hospitalization
研究概览
简要总结
This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.
详细描述
PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group.
OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included
排除标准
- •Patient is already taking chronic steroids
- •Patient is pregnant
- •Patient is decisionally impaired
- •Patient is a prisoner
研究组 & 干预措施
Corticosteroid
Participants in this group will receive a daily dose of corticosteroids on postoperative day one and two after spine fusion surgery
干预措施: Prednisone 20 Mg (Drug)
结局指标
主要结局
Morphine equivalent pain medication use over the length of hospitalization
时间窗: From postoperative admission to discharge, up to 4 weeks
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
Number of major complications reported during hospital stay after surgery
时间窗: From postoperative admission to discharge, up to 4 weeks
This will be measured in the total number of major complications (any) that occur during the hospital stay after surgery. These include, infection, neurological deficit, myocardial infarction, stroke, pneumonia, pulmonary embolism, and bleeding.
Length of hospital stay after surgery
时间窗: From postoperative admission to discharge, up to 4 weeks
This will be measured by taking the total minutes the patient stays in the hospital after surgery from time of admission to time of discharge.
Time to first bowel movement in hospital after surgery
时间窗: From postoperative admission to discharge, up to 4 weeks
This will be measured in the total number of minutes from admission after surgery that it takes for the patient to have their first bowel movement recorded.
Morphine equivalent pain medication use over the first 48 hours of hospitalization
时间窗: From postoperative admission to 48 hours after
This will be measured by converting the dosage of the pain medication administered to its equivalent dosage of morphine.
次要结局
未报告次要终点
研究者
Jung Yoo
Principal Investigator
Oregon Health and Science University