Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Last updated: August 1, 2023
Sponsor: Taipei Veterans General Hospital, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Pain

Chronic Pain

Treatment

Intercostal nerve blocks

Paravertebral block

Clinical Study ID

NCT04726930
2020-04-003B
  • Ages 20-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Intercostal nerve blocks
Phase:
Study Start date:
December 15, 2020
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Taipei Veterans General Hospital

    Taipei city, Taiwan, R.o.c. 11217
    Taiwan

    Active - Recruiting

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