Erector Spinea Plane BlockNCT06142630
Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
A study testing Alteration of patients' position after erector spinae plane block in people with Erector Spinea Plane Block, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
After the completion of erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spinea Plane Block
- What is being tested?
- Alteration of patients' position after erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 1 Dec 2024
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients received CT guided puncture localization of pulmonary nodules under local anesthesia
Who cannot join
- Allergic to local anesthetic
- History of opioid abuse
- Severe skin infection
- Peripheral neuropathy
- Dysfunction of blood coagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
After the completion of erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block.
Read the detailed description
Eighty-four patients were selected to undergo CT guided puncture localization of pulmonary nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Randomly divide patients into three groups: supine position group (S group, 28 patients), prone position group (P group, 28 patients), and lateral position group (L group, 28 patients). The patients underwent ultrasound guided ESPB on the puncture side before CT puncture localization. Ultrasound guided ESPB method: Using an ultrasound high-frequency linear array probe (5-13MHz, 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 short inclined plane puncture needle is used, and the needle is inserted from the head side using in-plane technology. After the needle tip reaches between the transverse process and erector spinae muscles, 1ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). After the block was completed, patients in Group S remained in a supine position; Patients in group L maintained the blocking side above; Patients in Group P maintained a prone position. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was LA-contrast spread to the paravertebral space.The second outcomes were as follow: 1. spread to the neural foramina 2. cranio-caudal spread 3. spread to the epidural space 4. spread to the intercostal space.
- Conditions
- Erector Spinea Plane Block
- Being tested
- Alteration of patients' position after erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteration of patients' position after erector spinae plane blockOther
After the erector spinae plane block was completed, the patients kept supine, lateral or prone position according to the group allocated for 30 minute to ensure the spread of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Supine group | No intervention | Patients remained supine |
| Prone group | Experimental | Patient remained prone Receives: Other: Alteration of patients' position after erector spinae plane block |
| Lateral position group | Experimental | Patient remained in a lateral position Receives: Other: Alteration of patients' position after erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and number of local anesthetic diffusion segment into the paravertebral space
Observation of local anesthetic spread spread into the paravertebral space with CT by a researcher who was blinded to group allocation
Measured: 30 minute after completion of the ESPB block
Secondary outcomes (3)
Diffusion of local anesthetic into intercostal space
The diffusion of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation
Measured: 30 minute 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 allocation
Measured: 30 minute after completion of the block
Sensory loss of cold
The extent of sensory loss was assessed with cold stimulation, including 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 minute immediately 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 posted21 Nov 2023
- Study start21 Nov 2023
- Primary completion15 Mar 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Erector Spinea 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu Jianping, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142630
- Sponsor's protocol ID
- KY20230915-04
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
PubMed 28447318Ueshima H, Otake H. RETRACTED: Erector spinae plane block provides effective pain management during pneumothorax surgery. J Clin Anesth. 2017 Aug;40:74. doi: 10.1016/j.jclinane.2017.04.016. Epub 2017 Apr 28. No abstract available.
PubMed 28625453Shan T, Zhang X, Zhao Z, Zhou X, Bao H, Su C, Tan Q, Han L, Yin J. Spread of local anaesthetic after erector spinae plane block: a randomised, three-dimensional reconstruction, imaging study. Br J Anaesth. 2025 Mar;134(3):830-838. doi: 10.1016/j.bja.2024.10.046. Epub 2025 Jan 8.
PubMed 39788818
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT06142630
- Acronym / sponsor ID
- KY20230915-04
- Conditions
- Erector Spinea Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Nov 2023 (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.
After the completion of erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block.
Detailed description
Eighty-four patients were selected to undergo CT guided puncture localization of pulmonary nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Randomly divide patients into three groups: supine position group (S group, 28 patients), prone position group (P group, 28 patients), and lateral position group (L group, 28 patients). The patients underwent ultrasound guided ESPB on the puncture side before CT puncture localization. Ultrasound guided ESPB method: Using an ultrasound high-frequency linear array probe (5-13MHz, 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 short inclined plane puncture needle is used, and the needle is inserted from the head side using in-plane technology. After the needle tip reaches between the transverse process and erector spinae muscles, 1ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). After the block was completed, patients in Group S remained in a supine position; Patients in group L maintained the blocking side above; Patients in Group P maintained a prone position. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was LA-contrast spread to the paravertebral space.The second outcomes were as follow: 1. spread to the neural foramina 2. cranio-caudal spread 3. spread to the epidural space 4. spread to the intercostal space.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine group | No intervention | –Patients remained supine |
| Prone group | Experimental | Other: Alteration of patients' position after erector spinae plane blockPatient remained prone |
| Lateral position group | Experimental | Other: Alteration of patients' position after erector spinae plane blockPatient remained in a lateral position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients received CT guided puncture localization of pulmonary nodules under local anesthesia
Key exclusion criteria (5 listed)
- Allergic to local anesthetic
- History of opioid abuse
- Severe skin infection
- 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 |
|---|---|---|
| Alteration of patients' position after erector spinae plane blockAfter the erector spinae plane block was completed, the patients kept supine, lateral or prone position according to the group allocated for 30 minute to ensure the spread of local anesthetic | Other | Lateral position group, Prone group |
Primary outcome
Incidence and number of local anesthetic diffusion segment into the paravertebral space
Time frame: 30 minute after completion of the ESPB block
Observation of local anesthetic spread spread into the paravertebral space with CT by a researcher who was blinded to group allocation
3 secondary outcomes
Diffusion of local anesthetic into intercostal space
Time frame: 30 minute after completion of the block
Diffusion of local anesthetic into the epidural space
Time frame: 30 minute after completion of the block
Sensory loss of cold
Time frame: 30 minute immediately after completion of the nerve block
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 10 Feb 2025.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 28447318Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
- Results publication: PubMed 28625453Ueshima H, Otake H. RETRACTED: Erector spinae plane block provides effective pain management during pneumothorax surgery. J Clin Anesth. 2017 Aug;40:74. doi: 10.1016/j.jclinane.2017.04.016. Epub 2017 Apr 28. No abstract available.
- Derived from this study: PubMed 39788818Shan T, Zhang X, Zhao Z, Zhou X, Bao H, Su C, Tan Q, Han L, Yin J. Spread of local anaesthetic after erector spinae plane block: a randomised, three-dimensional reconstruction, imaging study. Br J Anaesth. 2025 Mar;134(3):830-838. doi: 10.1016/j.bja.2024.10.046. Epub 2025 Jan 8.
- 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.
Gu Jianping 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 Alteration of patients' position after erector spinae plane block in people with Erector Spinea 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 1 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: finished, as of the sponsor's last update on 10 Feb 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?
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?
Incidence and number of local anesthetic diffusion segment into the paravertebral space (time frame: 30 minute 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?
On the ClinicalTrials.gov record for NCT06142630, which also lists 4 linked publications.
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 10 Feb 2025.