General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 120
- 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 study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.
详细描述
A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).
General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total hip arthroplasty (THA).
Primary endpoint:
LOS.
Secondary endpoints:
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 46 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with osteoarthritis scheduled for surgery
- •patients that will require THA
- •patients over 45 yrs and under 85 yrs.
- •patients that understand the given information and are willing to participate in this study
- •patients who have signed the informed consent document.
- •patients belonging to ASA class I-III.
排除标准
- •prior surgery to the same hip
- •patients with a history of stroke, neurological or psychiatric disease that potentially could affect the perception of pain
- •obesity (BMI > 35)
- •active or suspected infection
- •patients taking opioids or steroids
- •patients suffering from rheumatoid arthritis or an immunological depression
- •patients who are allergic to any of the drugs being used in this study
研究组 & 干预措施
RA-arm
RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
干预措施: RA-arm (Drug)
GA-arm, remifentanil
GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
干预措施: GA-arm, remifentanil (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: Up to 4 days after surgery
Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged
次要结局
- Post Operative Pain(from end of surgey until 48 hrs later)