Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Pain, Postoperative Clinical Trial

Official title: High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study

Status Recruiting

Clinical Trial Summary

To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.

Clinical Trial Description

Paravertebral (PVB) and intercostal nerve block (ICNB) are both techniques of injecting local anesthetics for pain management at thoracic and upper abdominal region. Today, PVB and ICNB are performed under the guidance of surface two dimensional B-mode ultrasound. However, the procedure still carries potential risks for inexperienced operators since the target zone is very close (2-3 mm) to the pleura. In certain patients, such as those with obesity, the steep needle trajectory and poor quality of the anatomic image make the nerve block even more difficult. Inaccurate identification of the anatomical structures or suboptimal positioning of the needle tip could result in complications and blockade failure. We designed an intra-needle ultrasound (INUS) system to improve the identification of anatomical structures and needle tip position. The system passed all safety standards including electrical safety test, biocompatibility test, software certification. This study is to investigate the feasibility and image quality of INUS during ICNB and PVB. The study protocol is approved and under monitoring for safety and compliance from both Institutional Review Board of Taipei Veterans General Hospital and Ministry of Health and Welfare, Taiwan, Republic of China. ;

Related Conditions & MeSH terms

• Acute Post-thoracotomy Pain
• Pain, Postoperative
• Thorax; Pain, Spine, With Radicular and Visceral Pain
• Ultrasound Therapy; Complications
• Visceral Pain

• NCT number: NCT04726930
• Study type: Observational
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: FU-WEI SU, MD
• Phone: +886-926037653
• Email: fuwei.su@gmail.com
• Status: Recruiting
• Start date: December 15, 2020
• Completion date: December 1, 2025