Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Taipei Veterans General Hospital

Status: Enrolling

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

Treatments: Procedure: Intercostal nerve blocks; Procedure: Paravertebral block

Study type: Observational

Funder types: Other

Identifiers

NCT04726930

2020-04-003B

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

40 participants in 4 patient groups

Intercostal nerve block with surface ultrasound

Description:

Number of participants: 10 Intercostal blocks will be performed under guidance of surface ultrasound. After we reach the injection site, the puncture stylet will be replace by Intra-needle ultrasound transducer (INUS). Collect signal from Intra-needle ultrasound transducer and then inject local anesthetics. Code name: ICNB-INUS-check

Treatment:

Procedure: Intercostal nerve blocks

Paravertebral block with surface ultrasound

Description:

Number of participants: 10 Paravertebral blocks will be performed under guidance of surface ultrasound. After we reach the injection site, the puncture stylet will be replace by Intra-needle ultrasound transducer (INUS). Collect signal from Intra-needle ultrasound transducer and then inject local anesthetics.

Treatment:

Procedure: Paravertebral block

Intercostal nerve block with intra-needle and surface ultrasound

Description:

Number of participants: 10 Intercostal blocks will be performed under guidance of intra-needle "and" surface ultrasound. The intra-needle transducer will be placed inside the puncture needle and it will be the primary guidance to reach target injection site. Surface ultrasound will be the secondary image guide for simultaneous comparison. Collect signal from both Intra-needle ultrasound transducer and surface ultrasound, and then inject local anesthetics. Code name: ICNB-INUS-guide

Treatment:

Procedure: Intercostal nerve blocks

Paravertebral nerve block with intra-needle and surface ultrasound

Description:

Number of participants: 10 Paravertebral blocks will be performed under guidance of intra-needle "and" surface ultrasound. The intra-needle transducer will be placed inside the puncture needle and it will be the primary guidance to reach target injection site. Surface ultrasound will be the secondary image guide for simultaneous comparison. Collect signal from both Intra-needle ultrasound transducer and surface ultrasound, and then inject local anesthetics. Code name: PVB-INUS-guide

Treatment:

Procedure: Paravertebral block