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临床试验/NCT05603442
NCT05603442已完成3 期

Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study

San Salvatore Hospital of L'Aquila2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年6月7日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
5
试验地点
2
主要终点
Epidural spread

研究概览

简要总结

The investigators hypothesize an alternative way to perform thoracic paravertebral block, by placing the needle tip over and behind the transverse process of vertebra, via the thoracic intervertebral foramen. This anesthetic procedure is called thoracic intervertebral foramen block.

The study aims to verify the spread of dye on to the the nervous structures of retropleural space (the ventral rami, the communicating rami, and the sympathetic trunk), and into the thoracic paravertebral space and epidural space. To accomplish this, a prospective cadaveric study was designed.

详细描述

This is a prospective cadaveric study. The anesthetic procedure is performed on 2 corpses for which autopsy is requested, in accordance with Italian Low.

Before performing the autopsy, the corps is placed in the left and then in the right lateral position, to perform bilateral block. The anesthetic procedure is performed at second (T2), fifth (T5), ninth (T9), and twelfth (T12) thoracic vertebra. The ultrasonography is performed by using a high-frequency linear-array US transducer. A Tuohy needle is inserted in-plane to the ultrasound beam in a lateral-to-medial direction gently to contact the spinous process, into the skeletal muscle plane of the erector spinae muscle. Then, the needle tip is moved to reach the angle between the transverse process and spinous process. Subsequently, the needle tip is gently inserted and advanced for 2 mm along with the superior limit of the vertebral pedicle, until losing contact with the bone. Five ml methylene blue 1% dye (MB) were subsequently injected. The anesthetic procedure is bilaterally performed. Two continuous catheter sets are used and threaded 1 cm from the needle tip, for a bilateral continuous block. The catheters are inserted from the caudal to the cephalic direction.

At the end of the anesthetic procedure, a second look ultrasound scan of thoracic paravertebral space was performed. Subsequently, the corps is put in supine position, and autopsy is started.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • corps for which autopsy is required

排除标准

  • corps under Legal custody of Italian Low

研究组 & 干预措施

Thoracic intervertebral foramen block

Experimental

The thoracic intervertebral foramen block is performed at second (T2), fifth (T5), ninth (T9), and twelfth (T12) thoracic vertebra. The ultrasonography is performed by using a high-frequency linear-array ultrasound transducer. A Tuohy needle is inserted in-plane to the ultrasound beam in a lateral-to-medial direction gently to contact the spinous process, into the skeletal muscle plane of the erector spinae muscle. Then, the needle tip is moved to reach the angle between the transverse process and spinous process. Subsequently, the needle tip is gently inserted and advanced for 2 mm along with the superior limit of the vertebral pedicle, until losing contact with the bone. Five ml methylene blue 1% dye (MB) are subsequently injected. The anesthetic procedure is bilaterally performed. Two continuous catheter sets were used and threaded 1 cm from the needle tip, for a bilateral continuous block. The catheters are inserted from the caudal to the cephalic direction.

干预措施: Thoracic intervertebral foramen block (Procedure)

结局指标

主要结局

Epidural spread

时间窗: During autopsy

Assess mL of dye on the epidural space

Thoracic paravertebral spread

时间窗: During autopsy

Assess mL of dye on to the thoracic paravertebral space

Retropleural spread

时间窗: During autopsy

Assess mL of dye on to the nervous structures of retropleural space (the ventral rami, the communicating rami, and the sympathetic trunk)

次要结局

  • Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is also evaluated(During autopsy)
  • Iatrogenic damages(During autopsy)
  • Second look ultrasound scan(After the anesthetic procedure)

研究者

发起方
San Salvatore Hospital of L'Aquila
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emiliano Petrucci

Medical doctor

San Salvatore Hospital of L'Aquila

研究点 (2)

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