Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Block performance time
研究概览
简要总结
The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers.
Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers.
The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol
- •Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)
排除标准
- •Volunteers not able to cooperate for the study
- •Volunteers not able to understand Danish
- •Daily use of analgesics
- •Allergy against the medicines used in the study
- •Drug abuse (according to the investigator's judgement)
- •Alcohol consumption larger than the recommendations of the Danish National Board of Health
- •Volunteers in whom nerve blocks are not possible due to technical reasons
- •Volunteers who meet any contraindication for MRI including claustrophobia
- •Volunteers who are incompetent, i.e. surrogate consent is not accepted
研究组 & 干预措施
Shamrock
Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.
干预措施: Lidocaine-adrenaline added gadolinium. (Drug)
Lumbar Ultrasound Trident
Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.
干预措施: Lidocaine-adrenaline added gadolinium. (Drug)
结局指标
主要结局
Block performance time
时间窗: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.
次要结局
- Number of needle feeds(Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Cost-effectiveness(Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.)
- Minimal electrical nerve stimulation(Estimated immediately before injection of local anesthetics during block placement)
- Sensor block(Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Epidural spread of local anesthetics with contrast(Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Type of response on electrical nerve stimulation(Assessed immediately before injection of local anesthetics during block placement)
- Perineural spread of local anesthetics with added contrast(Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Plasma Lidocaine(Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Depth of block needle(Estimated during block)
- Injection site(Estimated immediately after block placement)
- Discomfort during block placement(Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.)
- Mear arterial pressure(Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Motor block(Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)
- Block success rate(Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.)