Determination of Relationship Between Volume and Dispersion of Local Anesthetic on Ultrasound-guided Erector Spinae Plane Block in Cadavers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Spread of Coloring Solution secondary to volume injected and vertebral level of injection
研究概览
简要总结
This study aims to better understand the dispersion of local anesthetic on the Erector Spinae Block, a new technique developed for analgesia. It consists on injection of local anesthetic around the posterior muscles of the Spine. In this study, the investigators will make the injection with coloring solution on cadavers and by dissection will note the dispersion of the solution according to injectate volume. The investigators hypothesize more volume allows bigger spread and will allow new indications of this technique in perioperative analgesia and treatment of chronic Pain
详细描述
The study's methodology will include performing ultrasound guided erector spinae block in cadavers included in the study according to eligibility criteria. After signing of written consent form, the participants will be randomized on the height of the block (vertebral level - T3, T12 and L4) and the volume to be injected (10, 20 and 30ml). The block will be performed by experienced physicians on the technique by ultrasound guidance and fixed pressure measured with an in-line pressure monitor (15 psi) with the cadaver in the lateral position. The cadavers will be submitted to autopsy by standard thoracoabdominal midline incision, with the viscera removed for analysis. The cadavers will have their paraspinal muscles removed (quadratus lumborum and psoas major), the medial parietal pleura opened and the number of levels with colored solution registered, noting the spread to ventral rami of spinal nerves and to the paravertebral space.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fresh Cadavers (not subject to formaldehyde fixation process or frozen > 24h)
- •Age > 18 years
- •Written informed consent signed by responsible party
- •Height > 150cm and < 190cm
排除标准
- •Previous spinal surgery
- •Severe spinal deformity
- •BMI > 35 kg/m2
- •Absence of a responsible party to sign the written informed consent
研究组 & 干预措施
T3 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
T3 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T3 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
T3 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T3 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
T12 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T12 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
T12 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T12 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
T12 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T12 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
L4 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the L4 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
L4 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the L4 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
L4 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the L4 vertebral level
干预措施: Erector Spinae Plane Block (Procedure)
结局指标
主要结局
Spread of Coloring Solution secondary to volume injected and vertebral level of injection
时间窗: 3 hours
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected and injection site.
次要结局
- Spread of coloring solution to paravertebral space(3 hours)
研究者
Marcelo Vaz Perez
Medical Doctor
Federal University of São Paulo
