Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture: A Single-center Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Compartment pressure
研究概览
简要总结
There is a elevated risk of acute compartment syndrome (ACS) related to tibial shaft fractures due to oedema and reduced blood flow in traumatised tissues. This may lead to lack of oxygen and even necrosis. Symptoms of ACS are severe pain, hypoaesthesia, pain during flexion of the ankle and swollen leg in clinical examination. Paralysis and lack of distal pulses are late symptoms of ACS.
Many experts think that effective relief of pain caused by regional anaesthesia (RA) may hide the symptoms of the ACS. This may be incorrect. The evidence of dangers related to RA is based on old patient-series and single case-reports. Some of these studies report the symptoms of ACS (hypaesthesia and even pain) being caused by RA. Majority of the conclusions in these studies cannot be confirmed by an expert of RA. It is also possible that there are more hemodynamic changes related to general anaesthesia (GA) which may predispose to ACS. There are no modern, randomized and controlled studies of the safety of RA in patients with tibial shaft fracture.
详细描述
For some of the patients RA may be even more safe than GA. According to a large meta-analysis RA reduces the risk of several complications versus GA.
- Risk of deep vein thrombosis is reduced by 44%
- Risk of pulmonary embolism is reduced by 55 %
- Risk of major bleeding is reduced by 50%
- Risk of post operative pneumonia is reduced by 39%
- Risk of post operative respiratory is reduced by 59%
It is generally thought that RA is safer than GA for example in patients with heart or pulmonary diseases. It is also known that the use of RA reduces postoperative need of opioids, which leads to improved respiratory function and reduced post operative disorientation, delirium and nausea.
Purpose of the study: Our purpose is to gain more information of the safety of RA in patients with tibial fracture. Our hypothesis is that RA is equally safe with GA.
Implementation: Research begins with a pilot study in which RA is compared with GA. There are about 65 tibial fractures operated in our centre every year. We randomize patients to GA group (n=25) and spinal anaesthesia group (n=25). We presume that RA is equally safe with GA. However, power analysis has been made presuming that RA will increase the risk of ACS. We calculated the sample size by assuming that the compartment pressure in RA group is 10 mmHg higher than in the GA group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a unilateral tibial shaft fracture which needs to be operated are included.
排除标准
- •refusal of the patient
- •severe, generalized atherosclerosis
- •massive obesity
- •marked mental retardation, dementia
- •bilateral tibial shaft fracture
- •polytrauma, such as head injury
- •bleeding diathesis
- •aortic stenosis
- •infection at the injection site
- •certain medications affecting bleeding
- •hypovolemia
- •conversion to general anaesthesia due to technical difficulties
- •anesthesiologist has a strong opinion towards GA/RA
- •foreign patient and marked translation difficulties
研究组 & 干预措施
Spinal anesthesia
Spinal anesthesia
干预措施: General anesthesia (Procedure)
Spinal anesthesia
Spinal anesthesia
干预措施: Spinal anesthesia (Procedure)
General anesthesia
General anesthesia with fentanyl, propofol and rocuronium and sevoflurane
干预措施: General anesthesia (Procedure)
General anesthesia
General anesthesia with fentanyl, propofol and rocuronium and sevoflurane
干预措施: Spinal anesthesia (Procedure)
结局指标
主要结局
Compartment pressure
时间窗: 0-24 hours after surgery
Continuous measurement of anterior compartment pressure in the operated leg
次要结局
- INVOS values after surgery(0-24 hours after surgery)