- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06142630
Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block
February 6, 2025 updated by: Nanjing First Hospital, Nanjing Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nanjing
-
Nanjing, Nanjing, China, 210006
- Nanjing First Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Patients received CT guided puncture localization of pulmonary nodules under local anesthesia
Exclusion Criteria:
- Allergic to local anesthetic
- History of opioid abuse
- Severe skin infection
- Peripheral neuropathy
- Dysfunction of blood coagulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Supine group
Patients remained supine
|
|
|
Experimental: Prone group
Patient remained prone
|
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
|
|
Experimental: Lateral position group
Patient remained in a lateral position
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 minute after completion of the ESPB block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diffusion of local anesthetic into intercostal space
Time Frame: 30 minute after completion of the block
|
The diffusion of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation
|
30 minute after completion of the block
|
|
Diffusion of local anesthetic into the epidural space
Time Frame: 30 minute after completion of the block
|
Incidence and segment of local anesthetic spread into the epidural was assessed by a researcher who was blinded to group allocation
|
30 minute after completion of the block
|
|
Sensory loss of cold
Time Frame: 30 minute immediately after completion of the nerve block
|
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
|
30 minute immediately after completion of the nerve block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Gu JianPing, Nanjing First Hospital, Nanjing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Munoz 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.
- Ueshima 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2023
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
October 26, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 21, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 6, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- KY20230915-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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