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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05603442
Other study ID # 133/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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