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临床试验/NCT02911168
NCT02911168已完成不适用

A Prospective, Randomized Comparison Between the Ultrasound Guided Paravertebral Block and the Ultrasound Guided Proximal Intercostal Nerve Block

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Ultrasound Image Quality Score

研究概览

简要总结

The purpose of this study is to compare the proximal intercostal block to the more medial (classic) ultrasound-guided paravertebral block. The investigators hypothesize that the proximal intercostal block will allow for improved needle visualization, shorter block time, and improved safety profile compared to the classic paravertebral bock.

详细描述

Although previous studies have made advances towards applying ultrasound guidance to the performance of paravertebral blocks (PVB), a technique combining both safety and technical ease remains elusive. The ideal technique (1) permits continuous visualization of the entire needle shaft and tip, (2) avoids aiming the needle tip and injectate directly toward the neuraxis or lung, and (3) is easy to perform. Visualization of all structures by ultrasound is essential to minimize the risk of vascular puncture, nerve root or spinal cord injury, and pneumothorax. Failure to consistently and quickly identify the transverse process and pleura, as occurs when using older techniques, results in several needle redirections, causing pain and discomfort to patients, and increases the potential risk of pneumothorax. The technical difficulty of applying previously-described US-guided techniques takes an inordinate amount of time and is clinically less practical within a busy surgical practice.

In the current study, the investigators describe a novel, modified approach to real-time ultrasound-guided single shot paravertebral blockade, the proximal intercostal block (PICB), which utilizes a sagittal paramedian US probe placement to identify the intercostal space and PVS. In this method, instead of placing the probe at a fixed traditional distance of 2.5 cm from the spinous processes, the probe is moved laterally to obtain a comprehensive image, with a clear view of the ribs, internal intercostal membrane, and the parietal pleura.

The investigators propose that moving the probe laterally towards the proximal intercostal space allows clearer simultaneous visualization of both pleura and needle as it advances towards the PVS, while achieving comparable injectate spread and, ultimately, similar or better clinical results. Such improved visualization will reduce the number of needle passes, increase confidence in the user, decrease block placement time, and improve overall block success. This technique combines the advantages of more lateral approaches (better visualization of structures, in particular the pleura) with the advantage of the more medial approaches (in-plane, closer, and not directed at the neuraxis).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females age 18-85 years old
  • Patient scheduled for unilateral or bilateral mastectomy with or without reconstruction

排除标准

  • Coagulopathy
  • Patient refusal
  • Allergy to local anesthetics

结局指标

主要结局

Ultrasound Image Quality Score

时间窗: Evaluated at time of block

The following will be assessed for each image and video, and saved during each block performed: 1. Best possible image of block anatomy (including the pleura, transverse process/rib, costotransverse ligament/internal intercostal membrane, as appropriate) as well as needle location. 2. Video of the space during injection, reflecting the injectate spread. The images will be rated by a separate regional anesthesiologist not involved in study, but proficient with both types of blocks and ultrasound imaging. 3. The following score 3 point scale will be used to rate visibility: 0=not visible, 1=hardly visible, 2=well visible, 3=very well visible. Maximum score possible=18 including both pieces of media.

次要结局

  • Opioid requirement(Evaluated at 1 hour after extubation, and then at 24 hours following the block)
  • Number of Needle Passes(Established during block performance)
  • Effectiveness of the Block(One hour following extubation, and at 24 hours following block placement)
  • Prolonged postoperative pain(6 and 12 months after surgery)
  • Needling Time(Established during block performance)
  • Block Performance Time(Evaluated at time of block)
  • Imaging Time(Established during block performance)
  • Distance of Injection Sites from Midline(Established during block performance)
  • Presence of Perioperative Block-Related Complications(Within 24 hours of block placement)
  • Dermatomal spread(One hour following extubation)

研究者

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

Kamen Vlassakov

Principal Investigator

Brigham and Women's Hospital

研究点 (2)

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