Thoracic Intervertebral Foramen Block

NCT05603442 | Completed Phase 3 DMC

• 1 other identifier: 133/22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Functional; Anesthesia, Local; Spinal Cord

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Iatrogenic damages

  During autopsy

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

  During autopsy

• Second look ultrasound scan

  After the anesthetic procedure

Study Arms (1)

Thoracic intervertebral foramen block

EXPERIMENTAL

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

Interventions

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.

Thoracic intervertebral foramen block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• corps for which autopsy is required

You may not qualify if:

• corps under Legal custody of Italian Low

Sponsors & Collaborators

• San Salvatore Hospital of L'Aquila: lead

Study Sites (1)

San Salvatore Academic Hospital of L'Aquila

L’Aquila, L'Aquila, 67100, Italy

Location

Study Officials

• Emiliano Petrucci, MD

  San Salvatore Acadeci Hospital of L'Aquila (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 2, 2022
• Study Start: June 7, 2022
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)