Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block

Erector Spinea Plane Block Clinical Trial

Official title:

The Effects of Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142630
• Other study ID #: KY20230915-04
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shan Tao
• Phone: +8618852095135
• Email: 858727933[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After the completion of exploring the vertical erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block.

Description:

Thirty 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, 10 cases), prone position group (P group, 10 cases), and lateral position group (L group, 10 cases). The patient 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 fifth thoracic vertebrae. Under ultrasound, the transverse process and surface vertical 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 below the transverse process plane vertical spinal muscles, 2ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.375% ropivacaine 25ml+iohexol 5ml). 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 1 hour of block completion, CT scan and puncture localization were performed, followed by 3D reconstruction. Observation and recording of local anesthetic solution: 1. Diffusion range towards the head and tail; 2-way diffusion range of rib gap on one side 3; Diffusion to the paravertebral space; 4. Diffusion into the epidural space.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients received CT guided puncture localization of pulmonary nodules under local anesthesia

Exclusion Criteria:

1. Allergic to local anesthetic

2. History of opioid abuse

3. Severe skin infection

4. Peripheral neuropathy

5. Dysfunction of blood coagulation

Related Conditions & MeSH terms

• Erector Spinea Plane Block

Intervention

Other:
• Alteration of patients' position after erector spinae plane block
After the erector spinae plane block was completed, the patients kept lateral or prone position according to the group allocated for one hour to ensure the spread of local anesthetic

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour after completion of the ESPB block
Secondary	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	1 hour after completion of the block
Secondary	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	1 hour after completion of the block
Secondary	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	30 min and 60 min immediately after completion of the nerve block