Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
研究概览
简要总结
The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hip fracture within 48 hours of evolution
- •Known coronary artery disease:
- •Previous myocardial infarction Chronic stable angina Atypical angina with positive exercise test for coronary flow failure. Evidence of coronary artery disease with ultrasound, scintigraphic or angiographic compatible
- •Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)
排除标准
- •Patients receiving orthopedic treatment.
- •Patients with coagulopathy, clinic or laboratory.
- •Patients with sepsis or infection of the catheter insertion site of lumbar plexus.
- •Patients with neurological diseases evolving.
- •Patients disoriented, or dementia.
- •CKD stage IV National Kidney Foundation (2)
- •Glomerular filtration rate between 15 and 29 mL/min/1, 73 m2
- •Patients unable to use the Numeric Rating Scale (NRS) to assess pain.
- •Patients with non-sinus rhythm or conduction abnormalities (right bundle branch block or left, atrioventricular block) in the admission ECG
- •Patients with pacemaker.
- •Enrolled patients with acute coronary syndrome or decompensated cardiovascular disease at entry.
- •Allergy to any of the drugs of the protocol.
- •Inability to understand or unaided sign informed consent.
研究组 & 干预措施
Intravenous patient-controlled analgesia
Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes.
干预措施: Intravenous patient-controlled analgesia (Drug)
Continuous lumbar plexus (LP) block analgesia
Continuous lumbar plexus (LP) block analgesia. Continuous infusion of a solution of 0.1% bupivacaine in PCA mode, programmed at 8 ml / h.
Rescue bolus 5 ml and 30 minutes lockout
干预措施: Continuous lumbar plexus (LP) block analgesia (Procedure)
结局指标
主要结局
evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
时间窗: 3 days
次要结局
- Perioperative Pain Intensity, measured in numerical rating scale (NRS).(3 days)
- Death at 30, 90 and 360 days after surgery(1 year)
- Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).(3 days)
- hospital death(3 days)
- Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)(3 days)