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临床试验/NCT06936904
NCT06936904招募中不适用

Impact of Different Injection Rate on Local Anaesthetic Spread of Ultrasound-guided Erector Spinae Plane Block

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1
主要终点
Spread of local anesthetic into the paravertebral space

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected
  • •aged 18-80 years
  • •BMI 18-30 kg/m²
  • •ASA classification I-III

排除标准

  • •Allergy to the study drug or to local anesthetics
  • •History of opioid abuse
  • •Previous infection at the ESPB or PVB puncture site
  • •Peripheral neuropathy
  • •Dysfunction of blood coagulation

研究组 & 干预措施

Group C

Other

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.

干预措施: injection speed (Procedure)

Group S

Experimental

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.

干预措施: injection speed (Procedure)

结局指标

主要结局

Spread of local anesthetic into the paravertebral space

时间窗: 30 minutes after completion of the ESPB block

Observation of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation

次要结局

  • Diffusion of local anesthetic into intercostal space(30 minutes after completion of the block)
  • Diffusion of local anesthetic into the epidural space(30 minutes after completion of the block)
  • Diffusion of local anesthetic into the neural foramina(30 minutes after completion of the block)
  • Cephalocaudal spread of local anesthetic(30 minutes after completion of the block)
  • Loss to Cold Sensation of Skin(30 minutes after block)
  • NRS (Numeric Rating Scales) Score(1 hour after CT-guided nodule localization)
  • Hemodynamic profile(Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade)
  • Hemodynamic profile(Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tao Shan

Attending physician

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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