Pulmonary NodulesNCT07153263
Local Anaesthetic Spread and Sensory Block Range of the Retro-superior Costotransverse Ligament Space Block
A study testing Ultrasound-guided retro-SCTLB and Ultrasound-guided TPVB in people with Pulmonary Nodules and Nerve Block, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
The aim of this clinical trial is to investigate the effects of local anesthetic diffusion range and sensory block range during retro-SCTLB(retro superior costotransverse ligament space block) and TPVB(thoracic paravertebral block) in patients undergoing CT-guided lung nodule localization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodules, Nerve Block
- What is being tested?
- Ultrasound-guided retro-SCTLB and Ultrasound-guided TPVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 12 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected
- aged 18-80 years
- BMI 18-30 kg/m²
- ASA classification I-III
Who cannot join
- Allergy to the study drug or local anesthetic;
- History of opioid abuse;
- Pre-existing skin infection at the puncture site of ITPN or TPVB;
- Peripheral infectious neuropathy;
- Dysfunction of blood coagulation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tao Shan
Nanjing, Jiangsu, 210006
Tao Shan, +8618852095135, shantao2021@163.com
- Recruiting
Nanjing First Hospital
Nanjing
Tao Shan, MD, +8618852095135, 858727933@qq.com
About this study
Official title: Comparison of Local Anaesthetic Spread Between the Retro-superior Costotransverse Ligament Space Block and Thoracic Paravertebral Block: A Three-dimensional CT Reconstruction Imaging Study
The aim of this clinical trial is to investigate the effects of local anesthetic diffusion range and sensory block range during retro-SCTLB(retro superior costotransverse ligament space block) and TPVB(thoracic paravertebral block) in patients undergoing CT-guided lung nodule localization. The main issue of the study is to determine the differences in the diffusion range and sensory block range of local anesthetics between the retro-SCTLB and TPVB nerve block methods.
Read the detailed description
Fifty patients were selected to undergo CT guided puncture localization of lung nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Patients were randomly divided into two groups: the retro-SCTLB group (group R, 25 patients), and the TPVB group (group T, 25 patients). All patients underwent ultrasound guided retro-SCTLB or TPVB before CT-guided nodule localization. Ultrasound-guided retro-SCTLB method: Using an ultrasound low-frequency convex array probe (1-6 MHZ, Sonosite, USA), the probe was placed parallel to the spine 2-3cm outside the spinous process of the fifth thoracic vertebra, on the surface of the transverse process tip. First, the probe was placed above the rib and costo-transverse process joint and observed from the inside out to clearly show the spinous process, lamina, transverse process and rib. Then, the probe was gently moved towards the caudal side. Until the sound shadows of the ribs and transverse processes disappear and inferior articular processes appear on the medial side, and when high-echo superior ligaments of the costal transverse processes appear behind the paravertebral space and anterolateral of the inferior articular processes, then gently rotate the outer edge of the probe towards the caudal side and a low-echo area can be seen behind the superior ligaments of the costal transverse processes, which is the target area. Then, using a long oblique plane puncture needle, with the in-plane technique, insert the needle from the outer side of the probe. When the needle tip reaches the target area, use the water separation technique to inject 1ml of normal saline to confirm the needle tip position, then inject 20ml of local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) within 1 minute; Ultrasound-guided TPVB: Using an ultrasound low-frequency convex array probe (1-6 MHZ, Sonosite, USA), the probe is placed perpendicularly to the spine at the fifth thoracic vertebra on the midline of the trunk. First, the spinous process is identified, and then the ultrasound probe is gradually moved towards the surgical side. Structures such as the transverse process, pleura, and intercostal intima are visible. At this point, the ultrasound probe is moved parallel to the caudal side. The area between the parietal pleura, intercostal endometrium and transverse process is the target area for injection. Then, using a short inclined plane puncture needle, using the in-plane technique, the needle is inserted from the outside of the probe. When the needle tip reaches the target position, 1ml of normal saline is injected using the water separation technique to confirm the needle tip position. Then 20ml of local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected, and the injection is completed in 1 minute. 15 minutes after the block was completed, CT scans were performed and punctures were located, followed by three-dimensional reconstruction. Observe and record the local anesthetic solution: 1. The range of diffusion to the cranial and caudal side; 2 The range of diffusion to the intercostal space 3; The range of diffusion to the paravertebral space; 4. The range of diffusion to the epidural space; 5. The range of diffusion to the intervertebral foramen; 6. The range of diffusion to the anterolateral vertebrae (sympathetic ganglion).
- Conditions
- Pulmonary Nodules, Nerve Block
- Being tested
- Ultrasound-guided retro-SCTLB, Ultrasound-guided TPVB
- Keywords
- nerve block, TPVB, ITPB, rSCTL
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided retro-SCTLBProcedure or surgery
Patients undergoing CT-guided lung nodule localization were selected for the study. Before the surgery, the retro-SCTLB was performed under ultrasound guidance.
Ultrasound-guided TPVBProcedure or surgery
Patients undergoing CT-guided lung nodule localization were selected for the study. Before the surgery, the TPVB was performed under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| retro-SCTLB group | Experimental | A total of 20 ml of the local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected in the retro-superior costotransverse ligament space in the retro-SCTLB group within 60 seconds. Receives: Procedure: Ultrasound-guided retro-SCTLB |
| TPVB group | Experimental | A total of 20 ml of the local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected in the paravertebral space in the TPVB group within 60 seconds. Receives: Procedure: Ultrasound-guided TPVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spread of local anesthetic into the paravertebral space
Observation of incidence and thoracic level of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation
Measured: 15 minutes after completion of the nerve block
Secondary outcomes (6)
The range of the local anesthetic spreads to the intercostal space
Observation of incidence and thoracic level of local anesthetic spread into the intercostal space with CT by a researcher who was blinded to group allocation
Measured: 15 minutes after completion of the nerve block
Observation of local anesthetic spread cephalocaudally in the erector spinae plane
Observation of incidence and thoracic level of local anesthetic spread into the erector spinae plane cephalocaudally with CT by a researcher who was blinded to group allocation.
Measured: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the epidural space
Observation of incidence and thoracic level of local anesthetic spread into the epidural space with CT by a researcher who was blinded to group allocation
Measured: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the anterolateral vertebrae (sympathetic ganglion).
Observation of incidence and thoracic level of local anesthetic spread into the anterolateral vertebrae (sympathetic ganglion) with CT by a researcher who was blinded to group allocation
Measured: 15 minutes after completion of the nerve block
Assessment of skin sensory block with ice
The sensation of skin to cold was assessed with ice. The area includes the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall. The sensation was graded as 0 (no sensation), 1 (decreased sensation), or 2 (normal). A sensory block of the dermatome was considered to be achieved if the grade was either 0 or 1.
Measured: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the intervertebral foramen
Observation of incidence and thoracic level of local anesthetic spread into the intervertebral foramen with CT by a researcher who was blinded to group allocation
Measured: 15 minutes after completion of the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start12 Sep 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Shan, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Tao Shan, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153263
- Sponsor's protocol ID
- KY 20250819-10
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local Anaesthetic Spread Between the Retro-superior Costotransverse Ligament Space Block and Thoracic Paravertebral Block: A Three-dimensional CT Reconstruction Imaging Study
- ClinicalTrials.gov ID
- NCT07153263
- Acronym / sponsor ID
- KY 20250819-10
- Conditions
- Pulmonary Nodules, Nerve Block
- Keywords
- nerve block, TPVB, ITPB, rSCTL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Sep 2025 (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 aim of this clinical trial is to investigate the effects of local anesthetic diffusion range and sensory block range during retro-SCTLB(retro superior costotransverse ligament space block) and TPVB(thoracic paravertebral block) in patients undergoing CT-guided lung nodule localization. The main issue of the study is to determine the differences in the diffusion range and sensory block range of local anesthetics between the retro-SCTLB and TPVB nerve block methods.
Detailed description
Fifty patients were selected to undergo CT guided puncture localization of lung nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Patients were randomly divided into two groups: the retro-SCTLB group (group R, 25 patients), and the TPVB group (group T, 25 patients). All patients underwent ultrasound guided retro-SCTLB or TPVB before CT-guided nodule localization. Ultrasound-guided retro-SCTLB method: Using an ultrasound low-frequency convex array probe (1-6 MHZ, Sonosite, USA), the probe was placed parallel to the spine 2-3cm outside the spinous process of the fifth thoracic vertebra, on the surface of the transverse process tip. First, the probe was placed above the rib and costo-transverse process joint and observed from the inside out to clearly show the spinous process, lamina, transverse process and rib. Then, the probe was gently moved towards the caudal side. Until the sound shadows of the ribs and transverse processes disappear and inferior articular processes appear on the medial side, and when high-echo superior ligaments of the costal transverse processes appear behind the paravertebral space and anterolateral of the inferior articular processes, then gently rotate the outer edge of the probe towards the caudal side and a low-echo area can be seen behind the superior ligaments of the costal transverse processes, which is the target area. Then, using a long oblique plane puncture needle, with the in-plane technique, insert the needle from the outer side of the probe. When the needle tip reaches the target area, use the water separation technique to inject 1ml of normal saline to confirm the needle tip position, then inject 20ml of local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) within 1 minute; Ultrasound-guided TPVB: Using an ultrasound low-frequency convex array probe (1-6 MHZ, Sonosite, USA), the probe is placed perpendicularly to the spine at the fifth thoracic vertebra on the midline of the trunk. First, the spinous process is identified, and then the ultrasound probe is gradually moved towards the surgical side. Structures such as the transverse process, pleura, and intercostal intima are visible. At this point, the ultrasound probe is moved parallel to the caudal side. The area between the parietal pleura, intercostal endometrium and transverse process is the target area for injection. Then, using a short inclined plane puncture needle, using the in-plane technique, the needle is inserted from the outside of the probe. When the needle tip reaches the target position, 1ml of normal saline is injected using the water separation technique to confirm the needle tip position. Then 20ml of local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected, and the injection is completed in 1 minute. 15 minutes after the block was completed, CT scans were performed and punctures were located, followed by three-dimensional reconstruction. Observe and record the local anesthetic solution: 1. The range of diffusion to the cranial and caudal side; 2 The range of diffusion to the intercostal space 3; The range of diffusion to the paravertebral space; 4. The range of diffusion to the epidural space; 5. The range of diffusion to the intervertebral foramen; 6. The range of diffusion to the anterolateral vertebrae (sympathetic ganglion).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retro-SCTLB group | Experimental | Procedure: Ultrasound-guided retro-SCTLBA total of 20 ml of the local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected in the retro-superior costotransverse ligament space in the retro-SCTLB group within 60 seconds. |
| TPVB group | Experimental | Procedure: Ultrasound-guided TPVBA total of 20 ml of the local anesthetic solution (0.375% ropivacaine 10ml+ iohexol 10ml) is injected in the paravertebral space in the TPVB group within 60 seconds. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected
- aged 18-80 years
- BMI 18-30 kg/m²
- ASA classification I-III
Key exclusion criteria (5 listed)
- Allergy to the study drug or local anesthetic;
- History of opioid abuse;
- Pre-existing skin infection at the puncture site of ITPN or TPVB;
- Peripheral infectious neuropathy;
- Dysfunction of blood coagulation
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 |
|---|---|---|
| Ultrasound-guided retro-SCTLBPatients undergoing CT-guided lung nodule localization were selected for the study. Before the surgery, the retro-SCTLB was performed under ultrasound guidance. | Procedure or surgery | retro-SCTLB group |
| Ultrasound-guided TPVBPatients undergoing CT-guided lung nodule localization were selected for the study. Before the surgery, the TPVB was performed under ultrasound guidance. | Procedure or surgery | TPVB group |
Primary outcome
Spread of local anesthetic into the paravertebral space
Time frame: 15 minutes after completion of the nerve block
Observation of incidence and thoracic level of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation
6 secondary outcomes
The range of the local anesthetic spreads to the intercostal space
Time frame: 15 minutes after completion of the nerve block
Observation of local anesthetic spread cephalocaudally in the erector spinae plane
Time frame: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the epidural space
Time frame: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the anterolateral vertebrae (sympathetic ganglion).
Time frame: 15 minutes after completion of the nerve block
Assessment of skin sensory block with ice
Time frame: 15 minutes after completion of the nerve block
The range of the local anesthetic spread to the intervertebral foramen
Time frame: 15 minutes after completion of the nerve block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- 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.
Tao Shan study chair
Nanjing First Hospital, Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided retro-SCTLB and Ultrasound-guided TPVB in people with Pulmonary Nodules and Nerve Block, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Shan (+8618852095135, shantao2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spread of local anesthetic into the paravertebral space (time frame: 15 minutes after completion of the nerve block). 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 28 Aug 2026.