Erector Spinae Plane BlockNCT06936904
Different Injection Speed on Local Anaesthetic Spread of ESPB
A study testing injection speed in people with Erector Spinae Plane Block, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) 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
- Erector Spinae Plane Block
- What is being tested?
- injection speed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 1 Mar 2027
- 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 to local anesthetics
- History of opioid abuse
- Previous infection at the ESPB or PVB puncture site
- Peripheral neuropathy
- Dysfunction of blood coagulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu
YING ZHANG, 025-52271064
About this study
Official title: Impact of Different Injection Rate on Local Anaesthetic Spread of Ultrasound-guided Erector Spinae Plane Block
The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).
Read the detailed description
Senventy-four 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: control group (group C, 37 patients), and experimental group (group S, 37 patients). All patients underwent ultrasound guided ESPB before CT-guided nodule localization. Ultrasound guided ESPB method: Using a high-frequency linear probe (5-13 MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a long beveled needle is used, and inserted from the cephalad to caudal with in-plane technique. After the needle tip reaches between the transverse process and erector spinae muscles, 2ml saline is injected using water separation technique to confirm the position of the needle tip, then injecting 30ml local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). In the control group, the injection is administered at a rate of 30 ml within 180 seconds. In the experimental group, the injection is delivered at a faster rate of 30 ml withinr 30 seconds. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was mixture spread to the paravertebral space.The second outcomes were as follow: 1.spread to the intercostal space. 2. spread to the epidural space 3.spread to the neural foramina 4. cranio-caudal spread
- Conditions
- Erector Spinae Plane Block
- Being tested
- injection speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection speedProcedure or surgery
Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Other | A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group C, the injection is administered within 180 seconds. Receives: Procedure: injection speed |
| Group S | Experimental | A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group S, the injection is administered within 30 seconds. Receives: Procedure: injection speed |
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 local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation
Measured: 30 minutes after completion of the ESPB block
Secondary outcomes (8)
Diffusion of local anesthetic into intercostal space
The Incidence and thoracic level of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation.
Measured: 30 minutes after completion of the block
Diffusion of local anesthetic into the epidural space
Incidence and segment of local anesthetic spread into the epidural was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block
Measured: 30 minutes after completion of the block
Diffusion of local anesthetic into the neural foramina
Incidence and segment of local anesthetic spread into the neural foramina was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block
Measured: 30 minutes after completion of the block
Cephalocaudal spread of local anesthetic
Observation of local anesthetic spread cephalocaudally
Measured: 30 minutes after completion of the block
Loss to Cold Sensation of Skin
The sensation 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 (paraspinal zone) by a researcher who was blinded to group allocation.
Measured: 30 minutes after block
NRS (Numeric Rating Scales) Score
Numerical Rating Scale (NRS): This scale is composed of 11 numbers from 0 to 10, with higher numbers indicating greater pain intensity.Patients are required to select a number from 0 to 10 that best represents their current pain intensity based on patients' experience.
Measured: 1 hour after CT-guided nodule localization
Hemodynamic profile
Hemodynamic changes(Heart rate ) during blockade procedure
Measured: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Hemodynamic profile
Hemodynamic changes(Mean arterial pressure ) during blockade procedure
Measured: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start21 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 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
- NCT06936904
- Sponsor's protocol ID
- KY20250327-16
- Status last verified
- May 2025
- First submitted
- 13 Apr 2025
- Last updated
- 22 May 2025
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Injection Rate on Local Anaesthetic Spread of Ultrasound-guided Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT06936904
- Acronym / sponsor ID
- KY20250327-16
- Conditions
- Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Apr 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 effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).
Detailed description
Senventy-four 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: control group (group C, 37 patients), and experimental group (group S, 37 patients). All patients underwent ultrasound guided ESPB before CT-guided nodule localization. Ultrasound guided ESPB method: Using a high-frequency linear probe (5-13 MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a long beveled needle is used, and inserted from the cephalad to caudal with in-plane technique. After the needle tip reaches between the transverse process and erector spinae muscles, 2ml saline is injected using water separation technique to confirm the position of the needle tip, then injecting 30ml local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). In the control group, the injection is administered at a rate of 30 ml within 180 seconds. In the experimental group, the injection is delivered at a faster rate of 30 ml withinr 30 seconds. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was mixture spread to the paravertebral space.The second outcomes were as follow: 1.spread to the intercostal space. 2. spread to the epidural space 3.spread to the neural foramina 4. cranio-caudal spread
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Other | Procedure: injection speedA total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group C, the injection is administered within 180 seconds. |
| Group S | Experimental | Procedure: injection speedA total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group S, the injection is administered within 30 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 to local anesthetics
- History of opioid abuse
- Previous infection at the ESPB or PVB puncture site
- Peripheral 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 |
|---|---|---|
| injection speedPatients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed. | Procedure or surgery | Group C, Group S |
Primary outcome
Spread of local anesthetic into the paravertebral space
Time frame: 30 minutes after completion of the ESPB block
Observation of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation
8 secondary outcomes
Diffusion of local anesthetic into intercostal space
Time frame: 30 minutes after completion of the block
Diffusion of local anesthetic into the epidural space
Time frame: 30 minutes after completion of the block
Diffusion of local anesthetic into the neural foramina
Time frame: 30 minutes after completion of the block
Cephalocaudal spread of local anesthetic
Time frame: 30 minutes after completion of the block
Loss to Cold Sensation of Skin
Time frame: 30 minutes after block
NRS (Numeric Rating Scales) Score
Time frame: 1 hour after CT-guided nodule localization
Hemodynamic profile
Time frame: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Hemodynamic profile
Time frame: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
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 22 May 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection speed in people with Erector Spinae Plane Block, run by Nanjing First Hospital, Nanjing Medical University at 1 site 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 22 May 2025. 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 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: 30 minutes after completion of the ESPB 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 22 May 2025.