The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
研究概览
简要总结
Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a relevant technique in patients with severe cardiac comorbidity. The technique is a safer alternative compared to general or spinal anesthesia in these fragile patients.
The most recognized technique with ultrasound guidance (Karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. This may be fatal in high risk patients.
The investigators have developed a simple technique based on injection away from the spinal canal. The investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique.
This randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus.
The hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •ASA I (American Society of Anesthesiologists physical status classification)
排除标准
- •volunteers who are not able to cooperate
- •volunteers who do not understand and speak danish
- •daily use of analgesics
- •allergy to local analgesics or contrast agents
- •abuse of medicine or alcohol
- •volunteers with technical impediments of the planned interventions
结局指标
主要结局
Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
时间窗: 30 minutes after injection of local anesthetic
次要结局
- Block performance time(From start of probe on the skin until injection of local anesthetic is completed)
- Patient satisfaction(Immediately after completion of injection of local anesthetic)
- Mean arterial blood pressure (MAP)(5 minutes after completion of injection of local anesthetic)
- Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)(30 minutes after completed injection of local anesthetic)
- Motor blockade of the obturator nerve(40 minutes after completion of injection of the local anesthetic)
- Plasma lidocaine level (mcg/mL)(0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic)
- Cost-effectiveness(Block performance time period)
- Sensory blockade of the femoral nerve (cold, warmth, touch, pain)(30 minutes after completion of injection of local anesthetic)
- Motor blockade of the femoral nerve(40 minutes after completion of injection of the local anesthetic)
- Perineural spread of local anesthetic (with contrast) estimated with MRI(60 minutes after completion of injection of local anesthetic)
研究者
Thomas F. Bendtsen
Consultant anesthetist, associate professor
University of Aarhus