Thoracic Intervertebral Foramen Block

Anesthesia, Local Clinical Trial

Official title:

Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603442
• Other study ID #: 133/22
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: July 7, 2024

Study information

• Verified date: March 2024
• Source: San Salvatore Hospital of L'Aquila
• Contact: Emiliano Petrucci, MD
• Phone: +3908623681
• Email: petrucciemiliano[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: July 7, 2024
• Est. primary completion date: April 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• corps for which autopsy is required

Exclusion Criteria:

• corps under Legal custody of Italian Low

Related Conditions & MeSH terms

• Anesthesia, Local
• Anesthesia; Functional
• Spinal Cord

Intervention

Procedure:
• Thoracic intervertebral foramen block
The thoracic intervertebral foramen block is performed by placing the needle tip over and behind the transverse process of vertebra, via the thoracic intervertebral foramen.

Locations

Country	Name	City	State
Italy	San Salvatore Academic Hospital of L'Aquila	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retropleural spread	Assess mL of dye on to the nervous structures of retropleural space (the ventral rami, the communicating rami, and the sympathetic trunk)	During autopsy
Primary	Thoracic paravertebral spread	Assess mL of dye on to the thoracic paravertebral space	During autopsy
Primary	Epidural spread	Assess mL of dye on the epidural space	During autopsy
Secondary	Iatrogenic damages	Number of punctures of vertebral blood vessels, spinal nerve roots, and pleura	During autopsy
Secondary	Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is also evaluated	Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is evaluated	During autopsy
Secondary	Second look ultrasound scan	Area (square cm) of anechoic shadow on the paravertebral space	After the anesthetic procedure