Clinical trial NCT06936904: Different Injection Speed on Local Anaesthetic Spread of ESPB
Official title: Impact of Different Injection Rate on Local Anaesthetic Spread of Ultrasound-guided Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Spread of local anesthetic into the paravertebral space
timeFrame: 30 minutes after completion of the ESPB block
Secondary outcomes:
measure: Diffusion of local anesthetic into intercostal space
timeFrame: 30 minutes after completion of the block
measure: Diffusion of local anesthetic into the epidural space
timeFrame: 30 minutes after completion of the block
measure: Diffusion of local anesthetic into the neural foramina
timeFrame: 30 minutes after completion of the block
measure: Cephalocaudal spread of local anesthetic
timeFrame: 30 minutes after completion of the block
measure: Loss to Cold Sensation of Skin
timeFrame: 30 minutes after block
measure: NRS (Numeric Rating Scales) Score
timeFrame: 1 hour after CT-guided nodule localization
measure: Hemodynamic profile
timeFrame: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
measure: Hemodynamic profile
timeFrame: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Tao Shan
role: STUDY_CHAIR
References: