Anesthesia; FunctionalPhase 3NCT05603442
Thoracic Intervertebral Foramen Block
A Phase 3 study testing Thoracic intervertebral foramen block in people with Anesthesia; Functional and Anesthesia, Local, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia; Functional, Anesthesia, Local, Spinal Cord
- What is being tested?
- Thoracic intervertebral foramen block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jun 2022to 27 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- corps for which autopsy is required
Who cannot join
- corps under Legal custody of Italian Low
Trial locations and contacts
1 site in 1 country.
Italy1 site
San Salvatore Academic Hospital of L'Aquila
L’Aquila, L'Aquila, 67100
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia; Functional, Anesthesia, Local, Spinal Cord
- Being tested
- Thoracic intervertebral foramen block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic intervertebral foramen blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Thoracic intervertebral foramen block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retropleural spread
Assess mL of dye on to the nervous structures of retropleural space (the ventral rami, the communicating rami, and the sympathetic trunk)
Measured: During autopsy
Thoracic paravertebral spread
Assess mL of dye on to the thoracic paravertebral space
Measured: During autopsy
Epidural spread
Assess mL of dye on the epidural space
Measured: During autopsy
Secondary outcomes (3)
Iatrogenic damages
Number of punctures of vertebral blood vessels, spinal nerve roots, and pleura
Measured: 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
Measured: During autopsy
Second look ultrasound scan
Area (square cm) of anechoic shadow on the paravertebral space
Measured: After the anesthetic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start7 Jun 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Emiliano Petrucci, MD, Principal investigator, San Salvatore Acadeci Hospital of L'Aquila (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603442
- Sponsor's protocol ID
- 133/22
- Status last verified
- Nov 2024
- First submitted
- 21 Oct 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Intervertebral Foramen Block: a Prospective Cadaveric Study
- ClinicalTrials.gov ID
- NCT05603442
- Acronym / sponsor ID
- 133/22
- Conditions
- Anesthesia; Functional, Anesthesia, Local, Spinal Cord
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic intervertebral foramen block | Experimental | Procedure: Thoracic intervertebral foramen blockThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- corps for which autopsy is required
Key exclusion criteria (1 listed)
- corps under Legal custody of Italian Low
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic intervertebral foramen blockThe thoracic intervertebral foramen block is performed by placing the needle tip over and behind the transverse process of vertebra, via the thoracic intervertebral foramen. | Procedure or surgery | Thoracic intervertebral foramen block |
Primary outcome
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)
Thoracic paravertebral spread
Time frame: During autopsy
Assess mL of dye on to the thoracic paravertebral space
Epidural spread
Time frame: During autopsy
Assess mL of dye on the epidural space
3 secondary outcomes
Iatrogenic damages
Time frame: During autopsy
Distance (mm) between the catheter tip and the thoracic intervertebral foramen content is also evaluated
Time frame: During autopsy
Second look ultrasound scan
Time frame: After the anesthetic procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano Petrucci, MD principal investigator
San Salvatore Acadeci Hospital of L'Aquila (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thoracic intervertebral foramen block in people with Anesthesia; Functional and Anesthesia, Local, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retropleural spread (time frame: During autopsy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.