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.