Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Number of participants with a successful block of the femoral and obturator nerves (reduced muscle force compared to baseline assessed with handheld dynamometer), and of the lateral femoral cutaneous nerve (assessed with cold and pinprick test)
研究概览
简要总结
The main objective is to complete a double-blinded randomized controlled crossover trial of lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy volunteers.
The investigators will assess block procedure-related parameters, anatomical spread of local anesthetic, and motor and sensory effects.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Volunteers not abel to speak or understand Danish
- •Volunteers not able to cooperate
- •Allergy against the medicines used in the study
- •Daily use of analgesics
- •Drug abuse - according to the investigator's judgment
- •Alcohol consumption greater than the recommendations of the Danish National Board of Health
- •Contraindication for MRI scan (including pregnancy)
- •Volunteers in whom nerve blocks are impossible due to technical reasons or infection
- •Volunteers who are incompetent, eg. surrogate consent is unaccepted
研究组 & 干预措施
Shamrock guided by US/MR image fusion
Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
干预措施: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock) (Procedure)
Shamrock guided by US/MR image fusion
Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
干预措施: Lidocaine-epinephrine added gadoterate meglumine (Drug)
Shamrock guided by US
Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
干预措施: Ultrasound guided lumbar plexus block (Shamrock) (Procedure)
Shamrock guided by US
Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
干预措施: Lidocaine-epinephrine added gadoterate meglumine (Drug)
结局指标
主要结局
Number of participants with a successful block of the femoral and obturator nerves (reduced muscle force compared to baseline assessed with handheld dynamometer), and of the lateral femoral cutaneous nerve (assessed with cold and pinprick test)
时间窗: Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.
Block success is defined as the number of volunteers with a successful motor block of the femoral nerve and the obturator nerve, and with a successful sensory block of the lateral femoral cutaneous nerve. Motor block is a proxy marker of sensory block. A participant with a successful motor block has reduced muscle force after block compared to baseline muscle force assessed with handheld dynamometer, and a participant with a successful sensory block has decreased/absent sensation for cold and/or pinprick.
次要结局
- Electrical nerve stimulation strength (mA)(Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.)
- Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)(Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.)
- Injection site(Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.)
- Block needle depth(Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.)
- Discomfort(Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.)
- Mean arterial pressure change(Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.)
- Number of participants with visual confirmed contact between the injectate and the spinal nerves L2-S1, the femoral, the obturator, and the lateral femoral cutaneous nerves, and the lumbosacral trunk assessed on MRI(Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.)
- Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.(Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.)
- Number of participants with motor block(Baseline muscle strength is estimated prior to first intervention. Post-block muscle strength is estimated 60 minutes after intervention. Data will be presented 10 months after study completion.)
- Number of participants with sensory block(Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.)
- Cost-effectiveness (ICER)(Calculated 1 month after study completion. Data will be presented 10 months after study completion.)
- Quantitative diffusion weighted MRI reproducibility(Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.)
- Image evaluation of diffusion weighted MRI reproducibility(Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.)
- Time for preparation of block procedure (seconds)(Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.)
- Time for block procedure (seconds)(Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.)
- Needle advancements(Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.)