Comparison of Peripheral Nerve Blocks With General Anesthesia on Elderly Patients Undergoing Total Hip Replacement (THR) by Assessing the Postoperative Recovery and Delirium
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
研究概览
简要总结
Postoperative recovery is always worrisome to the elder patients undergoing Total Hip Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious papers suggested PNBs were commonly administered in conjunction with general anesthesia (GA), or the blocks were performed primarily for postoperative analgesia. Hardly any research has reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style for Total Hip Replacement (THR). The investigators compare peripheral nerve blocks to general anesthesia on elderly eld patients undergoing Total Hip Replacement (THR) by assessing the Postoperative Recovery and Delirium
详细描述
Patients will be followed by a blinded investigator for a 7days period to record the development of Cardiovascular and Pulmonary complications defined by a broad composite that included all-cause mortality, acute myocardial infarction, unstable angina, congestive heart failure, new atrial or ventricular dysrhythmia requiring treatment, cerebrovascular insult, pneumonia, and acute respiratory distress syndrome (ARDS).
Protocol This will be a randomized, prospective, single-center, assessor blinded study comparing two different anesthesia styles in 150 elderly patients undergoing primary total hip arthroplasty. We expect to enroll all patients in a 7 days period postoperation.
The study will be performed according to the Declaration of Helsinki principles, and written informed consent will be obtained from each patient. Preoperatively baseline values will be obtained for the cardiovascular, mental status, respiratory measures.
Mental status: During their preoperative visit patients will be given the neuropsychological tests in the Modified Mini-Mental State Examination. This extended measure of general cognition was developed to overcome shortcomings of the traditional Mini-Mental State Examination score, specifically its ceiling effects and narrow range of possible scores.
Each patient will be interviewed by the same trained research assistant before surgery and during the postoperative visits.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 75years old
- •Undergoing primary total uni-hip arthroplasty surgery
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Mini-Mental score examination (MMSE) being more than 23
排除标准
- •Patient refusal to participate in the study
- •Failure of regional block
- •Insulin dependent diabetes
- •Allergic to local anesthetics or general anesthetics
- •History of opioid dependence
- •Contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
- •Patient refusal to participate in the study
- •Current severe psychiatric disease or alcoholism or drug dependence
- •Severe visual or auditory disorder
结局指标
主要结局
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
时间窗: 7days
次要结局
- Postoperative Delirium(72 hours)
研究者
Junle Liu
Principal Investigator
Chinese PLA General Hospital