General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,396
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of this research is to compare post-operative outcomes from patients undergoing TJA. The study team wants to learn about outcomes like length of hospital stay, post-operative pain scores, post-operative nausea, deep and superficial surgical site infection, periprosthetic fracture (a broken bone that occurs around an orthopaedic implant), implant dislocation, readmission rates, and revision rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 undergoing a primary total hip or knee arthroplasty
- •Subjects must be capable of providing informed consent
- •English or Spanish speaking
排除标准
- •Patients with contraindications for spinal anesthesia such as:
- •Prior lumbar surgery with hardware insertion
- •Elevated intracranial pressure
- •Infection at the site of the procedure
- •Thrombocytopenia or coagulopathy
- •Severe mitral and aortic stenosis and left ventricular outflow obstruction
- •Severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication
- •Preexisting neurological disease
- •Patients with contraindications for general anesthesia such as:
- •Congestive heart failure
- •Severe aortic stenosis
- •Patient is unable/unwilling to consent
- •Current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study.
- •Prisoners
研究组 & 干预措施
General Anesthesia
Participants in this group will receive general anesthesia for TJA for up to 2 hours.
干预措施: General Anesthesia (Procedure)
Spinal Anesthesia
Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.
干预措施: Spinal Anesthesia (Procedure)
结局指标
主要结局
Length of hospital stay
时间窗: Up to 72 hours.
Will be measured in hours.
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
时间窗: Baseline (up to 1 hour after surgery), up to 24 hours.
Score range from 0 to 10, higher score indicate higher pain scores.
Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria
时间窗: Baseline (up to 1 hour after surgery), up to 24 hours.
Score range from 0 to 9, higher score indicate higher nausea scores.
Number of implant dislocation.
时间窗: Up to 90 days.
Will be measured by the number of implant dislocation.
Prosthetic joint infection
时间窗: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Superficial surgical site infection
时间窗: Up to 90 days.
Will be measured by the 2018 Musculoskeletal Infection Society criteria.
Number of periprosthetic fracture
时间窗: Up to 90 days.
Will be measured by the number of periprosthetic fracture.
Number of participants who are readmitted 90 days after surgery.
时间窗: Up to 90 days.
Will be measured by the number of participants who are readmitted 90 days after surgery.
Number of participants who receive revision surgery 90 days after surgery.
时间窗: Up to 90 days.
Will be measured by the number of participants who receive revision surgery 90 days after surgery.
Number of participant deaths.
时间窗: Up to 90 days.
Will be measured by the number of participants deaths.
次要结局
- Length of surgery.(Up to 2 hours.)
研究者
Victor Hugo Hernandez
Professor of Clinical
University of Miami