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Clinical Trials/NCT05603442
NCT05603442
Completed
Phase 3

Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study

San Salvatore Hospital of L'Aquila1 site in 1 country5 target enrollmentJune 7, 2022

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anesthesia; Functional
Sponsor
San Salvatore Hospital of L'Aquila
Enrollment
5
Locations
1
Primary Endpoint
Epidural spread
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2022
End Date
November 27, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
San Salvatore Hospital of L'Aquila
Responsible Party
Principal Investigator
Principal Investigator

Emiliano Petrucci

Medical doctor

San Salvatore Hospital of L'Aquila

Eligibility Criteria

Inclusion Criteria

  • corps for which autopsy is required

Exclusion Criteria

  • corps under Legal custody of Italian Low

Outcomes

Primary Outcomes

Epidural spread

Time Frame: During autopsy

Assess mL of dye on the epidural space

Thoracic paravertebral spread

Time Frame: During autopsy

Assess mL of dye on to the thoracic paravertebral space

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)

Secondary Outcomes

  • Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is also evaluated(During autopsy)
  • Iatrogenic damages(During autopsy)
  • Second look ultrasound scan(After the anesthetic procedure)

Study Sites (1)

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