Thoracic Intervertebral Foramen Block

Sponsor
San Salvatore Hospital of L'Aquila (Other)
Overall Status
Recruiting
CT.gov ID
NCT05603442
Collaborator
(none)
5
1
1
13
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thoracic intervertebral foramen block
N/A

Detailed 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 sixth (T6) and at tenth thoracic vertebra (T10). 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study
Actual Study Start Date :
Jun 7, 2022
Anticipated Primary Completion Date :
Dec 7, 2022
Anticipated Study Completion Date :
Jul 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thoracic intervertebral foramen block

The thoracic intervertebral foramen block is performed at sixth (T6) and at tenth thoracic vertebra (T10). 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Retropleural spread [During autopsy]

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

  2. Thoracic paravertebral spread [During autopsy]

    Assess mL of dye on to the thoracic paravertebral space

  3. Epidural spread [During autopsy]

    Assess mL of dye on the epidural space

Secondary Outcome Measures

  1. Iatrogenic damages [During autopsy]

    Number of punctures of vertebral blood vessels, spinal nerve roots, and pleura

  2. Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is also evaluated [During autopsy]

    Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is evaluated

  3. Second look ultrasound scan [After the anesthetic procedure]

    Area (square cm) of anechoic shadow on the paravertebral space

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • corps for which autopsy is required
Exclusion Criteria:
  • corps under Legal custody of Italian Low

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Salvatore Academic Hospital of L'Aquila L'Aquila Italy 67100

Sponsors and Collaborators

  • San Salvatore Hospital of L'Aquila

Investigators

  • Principal Investigator: Emiliano Petrucci, MD, San Salvatore Acadeci Hospital of L'Aquila (Italy)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emiliano Petrucci, Medical doctor, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier:
NCT05603442
Other Study ID Numbers:
  • 133/22
First Posted:
Nov 2, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 23, 2022