Enhanced Recovery After Spine Surgery (ERASS) Versus Traditional Spine Surgical Care (TC): A Randomized, Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Opioid use during hospitalization
研究概览
简要总结
The purpose of this study is to compare two different approaches to the care patients receive before, during and after their spinal surgery and to determine if either approach has a significant difference in patient outcomes, opioid use, and recovery following spine surgery. The study will compare the standard-of-care surgical approach taken at the Hospital of the University of Pennsylvania with the Enhanced Recovery After Spine Surgery (ERASS) pathway. ERASS is a program that will provide additional education before your surgery, reduce your opioid consumption, and provide earlier physical therapy than you would normally receive under the standard-of-care approach, among other protocols outlined in this consent. Patients will be randomized to receive either of these approaches and the researchers will collect information to better understand if the ERASS approach provides more patient benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 18 and older (both male and female), who present to the department of neurosurgery at the Hospital of the University of Pennsylvania and who are determined to require elective spine surgery with one of two senior spine neurosurgeons, Drs. Malhotra and Marcotte.
排除标准
- •Patients who are pregnant
- •Incarceration
- •Patients under the age of 18
- •Patients unable to participate in the consent procedure
- •Patients undergoing emergent surgery
- •Patients with liver disease
结局指标
主要结局
Opioid use during hospitalization
时间窗: post-operative days during hospital admission, up to 20 days
Total opioid use during hospitalization after surgery
Opioid use after surgery
时间窗: up to one month after surgery
Proportion of patients using opioids one month after surgery
次要结局
- Opioids Left Over After Surgery(up to one month after surgery)
- Total Opioid Consumption During Hospitalization Using Morphine Equivalents(post-operative days during hospital admission, up to 20 days)
- Opioid Consumption During Hospitalization(post-operative days during hospital admission, up to 20 days)
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Engagement(Up to 3 months after surgery)
- Mobilization During Hospitalization(post-operative days 0 and 1 during hospital admission)
- Usage of Foley During Hospitalization Course(from admission to discharge, up to 20 days)
- Length of Stay (hours)(from admission to discharge, up to 20 days)
- Collection of Patient Re-admissions After Discharge(up to 3 months after surgery)
- Patient Reported Outcomes EQ-5D (health scale)(prior to surgery, up to 6 months after surgery)
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Compliance(Up to 3 months after surgery)
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Medication(Up to 3 months after surgery)
- Usage of Straight Catheterization During Hospitalization Course(from admission to discharge, up to 20 days)
- Collection of Inpatient Status(from admission to discharge, up to 20 days)
- Time to Mobilization During Hospitalization(post-operative days during hospital admission, up to 20 days)
- Usage of PCA during hospitalization(from admission to discharge, up to 20 days)
- Opioid Refills After Surgery(up to one month after surgery)
- Opioid Prescribed After Surgery(up to one month after surgery)
- Opioid Refills (days) After Surgery(up to one month after surgery)
- Opioid Compliance During Hospitalization(from admission to discharge, up to 20 days)
- Pain Control Medication Usage(post-operative days during hospital admission, up to 20 days)
- Pain Control Measurement(from admission to discharge, up to 20 days)
- Patient Falls(from admission to discharge, up to 20 days)
- Length of Stay (days)(from admission to discharge, up to 20 days)
- Patient Reported Outcomes Oswestry Low Back Pain Disability Questionnaire(prior to surgery, up to 6 months after surgery)
- Patient Reported Outcomes Neck Disability Index(prior to surgery, up to 6 months after surgery)
- Patient Reported Outcomes Neurosurgery Patient Satisfaction(prior to surgery, up to 6 months after surgery)
- Consults(Prior to surgery)
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Patient Enrollment(Up to 3 months after surgery)
- Enhanced Recovery at Penn (ERAP) Text Messaging Program - Pain Score(Up to 3 months after surgery)
- Collection of Patient Complications(from admission to discharge, up to 20 days and up to 6 months after surgery)
- Collection of Discharge Disposition(from admission to discharge, up to 20 days)
- Compliance During Hospitalization(from admission to discharge, up to 20 days)
- Collection of Working Status(prior to surgery, up to 6 months after surgery)
- Collection of Re-operation After Surgery(up to 3 months after surgery)
- Discharge Follow Up Questionnaire(prior to surgery, up to 2-6 weeks after discharge from the hospital)
- Patient Reported Outcomes EQ-5D(prior to surgery, up to 6 months after surgery)
研究者
Zarina Ali
Chief, Penn Presbyterian Medical Center Department of Neurosurgery
University of Pennsylvania