Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation?
试验速览
- 阶段
- 4 期
- 入组人数
- 269
- 试验地点
- 4
- 主要终点
- percentage of patients with effective regional analgesia
研究概览
简要总结
Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective primary total hip arthroplasty under general anaesthesia
- •Able to give informed consent
- •Able to cooperate with sensory and motor testing of lower limb function
排除标准
- •Abnormal clotting screen (coagulopathy) or thrombocytopenia (<100,000)
- •Acute mental test score of <=7 at any time pre or post operatively
- •Allergy to local anaesthetic
- •Signs, symptoms or laboratory evidence of local infection or systemic sepsis
- •No pre-existing neurological deficit (sensory or motor) affecting lower limb
- •Patients with lower limb amputations
研究组 & 干预措施
nerve stimulator
Anterior psoas compartment nerve block inserted using nerve stimulator
干预措施: nerve stimulator (Procedure)
nerve stimulator
Anterior psoas compartment nerve block inserted using nerve stimulator
干预措施: determination of method with highest efficacy (ultrasound or nerve stimulator) (Procedure)
loss of resistance
Anterior psoas compartment nerve block inserted using loss of resistance
干预措施: loss of resistance (Procedure)
ultrasound
Anterior psoas compartment nerve block inserted using ultrasound
干预措施: determination of method with highest efficacy (ultrasound or nerve stimulator) (Procedure)
结局指标
主要结局
percentage of patients with effective regional analgesia
时间窗: Induction of anaesthesia
次要结局
- sensory function of femoral nerve(0mins, 10mins, 20mins after insertion of local anesthetic)
- sensory function in lateral cutaneous nerve(0mins, 10mins 20mins post insertion of local anaesthetic)
- sensory function of obturator nerve(0mins, 10mins, 20mins after insertion of local anesthetic)
- motor function of obturator nerve(0mins, 10mins and 20minutes after insrtion of local anesthetic)
- day first mobilise post operatively(post operatively 0-10 days)
- patient satisfaction scores(6 hours and 24hours post operatively)
- hospital mortality(1months after operation)
- total morphine dose administered(6hours and 24 hours post operstively)
- acute mental test scores(6hours and 24 hours post operatively)
- motor function of femoral nerve(0mins,10mins and 20mins post insertion of local anesthetic)