Thoracic Intervertebral Foramen Block

Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Anesthesia; Functional; Spinal Cord
• Intervention / Treatment: Procedure: Thoracic intervertebral foramen block

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 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • San Salvatore Academic Hospital of L'Aquila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• corps for which autopsy is required

Exclusion Criteria:

• corps under Legal custody of Italian Low

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Thoracic intervertebral foramen block; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Thoracic paravertebral spread	Assess mL of dye on to the thoracic paravertebral space	During autopsy
Epidural spread	Assess mL of dye on the epidural space	During autopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iatrogenic damages	Number of punctures of vertebral blood vessels, spinal nerve roots, and pleura	During autopsy
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
Second look ultrasound scan	Area (square cm) of anechoic shadow on the paravertebral space	After the anesthetic procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 133/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No