Different Injection Speed on Local Anaesthetic Spread of ESPB

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).

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block
• Intervention / Treatment: Procedure: injection speed

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 Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Shan; Phone Number: +8618852095135; Email: shantao2021@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing First Hospital
      • Contact: YING ZHANG; Phone Number: 025-52271064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected

1. aged 18-80 years
2. BMI 18-30 kg/m²
3. ASA classification I-III

Exclusion Criteria:

1. Allergy to the study drug or to local anesthetics
2. History of opioid abuse
3. Previous infection at the ESPB or PVB puncture site
4. Peripheral neuropathy
5. Dysfunction of blood coagulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group C; 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.	Procedure: injection speed; 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.
Experimental: Group S; 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.	Procedure: injection speed; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 minutes after completion of the ESPB block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic profile	Hemodynamic changes(Heart rate ) during blockade procedure	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	Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
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.	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	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	30 minutes after completion of the block
Cephalocaudal spread of local anesthetic	Observation of local anesthetic spread cephalocaudally	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.	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.	1 hour after CT-guided nodule localization

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Tao Shan, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 13, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KY20250327-16

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