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NCT Number: NCT05603442

Thoracic Intervertebral Foramen Block

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.

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Key information

Conditions

Anesthesia; Functional Anesthesia, Local Spinal Cord

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Salvatore Academic Hospital of L'Aquila

L’Aquila, L'Aquila, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • corps for which autopsy is required

Exclusion criteria

  • corps under Legal custody of Italian Low

Treatment and study plan

Thoracic intervertebral foramen block

Procedure

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.

Primary outcomes

  1. Retropleural spread

    Time frame: 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

    Time frame: During autopsy

    Assess mL of dye on to the thoracic paravertebral space

  3. Epidural spread

    Time frame: During autopsy

    Assess mL of dye on the epidural space

Secondary outcomes

  1. Iatrogenic damages

    Time frame: 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

    Time frame: During autopsy

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

  3. Second look ultrasound scan

    Time frame: After the anesthetic procedure

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

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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