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Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Recruiting
20-80 years
All
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria:

  1. Patients scheduled for elective thoracic surgery
  2. Patients scheduled for elective upper abdominal surgery
  3. Patients scheduled for elective breast surgeries.

Exclusion Criteria:

  1. Known coagulopathies,
  2. Skin lesion or infection at site of nerve block
  3. Pregnant women
  4. Allergic to local anesthetics
  5. Cognitive diseases
  6. Unstable hemodynamics
  7. Chronic substance abuse (ex. alcohol, hypnotics, opioids)

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

NCT04726930

Taipei Veterans General Hospital, Taiwan

25 January 2024

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