Determination of the Minimum Local Anaesthetic Needed for Operative Fixation of Fractured Neck of Femur With Continuous Spinal Anaesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- MLAD of 0.5 % bupivacaine for operative fixation of fractured neck of femur patients
研究概览
简要总结
Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be challenging in some cases like in haemodynamical unstable patients.
The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is still unknown.
A step-up/step-down methodology was used successfully in regional anaesthesia and also in other areas of anaesthesia.
In pregnant ladies in whom spinal anaesthesia is performed on the side, significant correlation exist between the vertebral length measured from cervical 7 to the iliac creast and MLAD.
The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required for Continuous spinal anaesthesia for the operative fixation of FNF.
详细描述
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients and requires operative fixation. Spinal anaesthesia (SA) is one of the options, since 1899 when Bier described first administration this technique went through many changes. Spinal anaesthesia has the definitive advantage that profound nerve block can be produced in a large part of the body by the relatively simple injection of a small amount of local anaesthetic. Although in some cases single shot SA is contraindicated or can have severe haemodynamic side effects. In elderly patients undergoing hip fracture repair, continuous spinal anaesthesia (CSA) provides fewer episodes of hypotension and severe hypotension compared with a single intrathecal injection of 7.5 mg bupivacaine.
We have evidence of minimum effective local anaesthetic dose (MLAD) in hip replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is still unknown. It would however be beneficial for those patients who are haemodinamicaly unstable. A step-up/step-down methodology was used successfully in regional anaesthesia and also in other areas of anaesthesia.
In pregnant ladies in whom spinal anaesthesia is performed on the side, significant correlation exist between the vertebral length measured from cervical 7 to the iliac creast and MLAD.
We propose to study the MLAD for continuous spinal anaesthesia (CSA) for the operative fixation of FNF.
Objectives: We would like to determine the MLAD of hyperbaric 0.5% bupivacaine required for CSA for the operative fixation of FNF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Above 60 years
- •ASA I to III patients
排除标准
- •Patient refusal
- •Outside Age Range
- •Coagulation disorders
- •Head injury or other associated injuries
- •Loss of consciousness and signs of acute coronary syndrome
- •Mini-Mental Score < 25
- •Allergy to bupivacaine, lignocaine
- •Skin lesions/infection at site of injection
结局指标
主要结局
MLAD of 0.5 % bupivacaine for operative fixation of fractured neck of femur patients
时间窗: In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed
Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s.
次要结局
- MLAD/ vertebral length(In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed)
- Pain experienced by the patients in the operating theatre.(In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed)
- Patient satisfaction after surgery regarding pain relief.(In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed)
- Difference (if any) in effect on haemodynamic variables (i.e. heart rate and blood pressure).(After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously)
- Side effects of medication(After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously)
研究者
Szilard Szucs
Clinical Tutor in Anaesthesia
Cork University Hospital