A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,848
- 试验地点
- 88
- 主要终点
- Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance
研究概览
简要总结
The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.
详细描述
Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.
Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.
No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia, making the anesthetic care episode a major opportunity to impact outcomes.
Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.
REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
- •Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
- •Ability to walk 10 feet or across a room without human assistance before fracture
排除标准
- •Planned concurrent surgery not amenable to spinal anesthesia
- •Absolute contraindications to spinal anesthesia
- •Periprosthetic fracture
结局指标
主要结局
Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance
时间窗: Approximately 60 days after Randomization
Will be assessed via telephone interview
次要结局
- Chronic Pain(Approximately 60, 180, and 365 days after randomization)
- Cognitive Function(Baseline and approximately 60, 180, and 365 days after randomization)
- Need for Assistive Devices for Walking(Approximately 60, 180, and 365 days after randomization)
- Postoperative Delirium(Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first)
- Inpatient Mortality(During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first)
- Major Inpatient Morbidity(During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first)
- Overall Health and Disability(Approximately 60, 180, and 365 days after randomization)
- Ability to Return to Home(Approximately 60, 180, and 365 days after randomization)
- All-cause Mortality(Approximately 60, 180, and 365 days after randomization)
- Satisfaction With Care(Postoperative day 3 or day of discharge, whichever occurs first)
- Acute Postoperative Pain(Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first)