General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial
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
- 2
- 主要终点
- time from end of surgery until patient is "street ready"
研究概览
简要总结
Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty.
Primary endpoint: time from end of surgery until the patient is "street ready"
Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative "dizziness" between the groups.
详细描述
Hypothesis
General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA).
Primary endpoint: time from end of surgery until the patient meets the discharge criteria.
Secondary endpoints:
- Will general anesthesia produce less post operative pain?
- Is there any difference in post operative orthostatic function (dizziness) between the groups?
- Time until the patient meets the discharge criteria from PACU
- How many patients will need at least one urinary bladder catheterization?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 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 Total Knee Arthroplasty
- •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
排除标准
- •prior surgery to the same knee
- •patients with a history of stroke or 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 have a immunological depression.
- •patients who are allergic to any of the drugs being used in this study
- •patients with other severe medical problems that could affect the perioperative course.
结局指标
主要结局
time from end of surgery until patient is "street ready"
时间窗: within 4 days after surgery
Time from end of surgery until the patient is street ready will be monitored. If the patient is street ready will be evaluated twice daily each day after the surgery.
次要结局
- Will general anesthesia produce less post operative pain as compared to intrathecal?(48 hrs after surgery)