Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
This study evaluates the effect of anesthesia on mortality after surgical repair of proximal femur fracture.
Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks and light general anesthesia (PNB/GA).
The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid free light anesthesia may have more favourable outcomes.
Both groups will be followed up for assessment of post-operative morbidity and mortality.
详细描述
Proximal femur fracture is one of the most common causes of admission in emergency departments. Mortality is high among these patients and is reported to range from 10% at 30 days, up to 32% at one-year post-operative.
Several strategies to reduce mortality have been used, but mortality rate has plateaued since 1998. Attempts to show benefit from regional or general anesthesia have shown inconsistent results. New techniques with peripheral nerve blocks have been used, but their effect on mortality when used as major anesthesia component have not been studied.
The investigators hypothesise that smaller physiologic impact of peripheral nerve blocks associated to light general anesthesia may improve survival rates and reduce short term delirium after proximal femur fracture surgery. Recovery of quality of life will also be assessed.
Patients will be randomized into two groups, being allocated for a subarachnoid anesthesia or a combination of peripheral nerve blocks and light general anesthesia.
Patients will be followed up for short-term post-operative complications such as incidence of delirium, recovery of quality of life and survival up to one year.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted wiht a diagnosis of proximal femur fracture (ICD-9 codes 820.0 to 820.9) and submitted to surgical internal fixation of femur or hip prosthesis (ICD-9 codes 7935, 8151 and 8152)
排除标准
- •Multiple fractures; polytrauma, active malignancy, ASA(American Society of Anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, contra-indication to general or regional anesthesia
研究组 & 干预措施
Subarachnoid anesthesia
Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair.
Up to 12.5 mg of bupivacaine or levobupivacaine will be used
干预措施: Subarachnoid Anesthesia (Procedure)
Subarachnoid anesthesia
Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair.
Up to 12.5 mg of bupivacaine or levobupivacaine will be used
干预措施: bupivacaine or levobupivacaine (Drug)
PNB/GA
Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane
干预措施: PNB/GA (Procedure)
PNB/GA
Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane
干预措施: ropivacaine (Drug)
PNB/GA
Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane
干预措施: sevoflurane or desflurane (Drug)
结局指标
主要结局
Survival rate
时间窗: up to one year post-operative
次要结局
- Quality of Life Recovery(Up to one year post-operative)
- Incidence of post-operative delirium(Up to one week post-operative)
研究者
Raul Carvalho
Raul Carvalho, MD, MSc
Centro Hospitalar do Porto