Ultrasound Needle Transducer for Regional Anesthesia Validation Study

NCT ID: NCT04726930

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2025-12-01

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Intercostal nerve block with surface ultrasound

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

Intercostal nerve blocks

Intervention Type: PROCEDURE

Intercostal nerve block is a regional anesthetic procedure for peri-operative pain management. It inhibits the action of the ipsilateral sensory and motor branches, and produces analgesic effects at the targeted thoracic level.

Paravertebral block with surface ultrasound

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.

Paravertebral block

Intervention Type: PROCEDURE

Paravertebral block is the technique of injecting local anesthetic alongside the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen

Intercostal nerve block with intra-needle and surface ultrasound

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

Intercostal nerve blocks

Intervention Type: PROCEDURE

Intercostal nerve block is a regional anesthetic procedure for peri-operative pain management. It inhibits the action of the ipsilateral sensory and motor branches, and produces analgesic effects at the targeted thoracic level.

Paravertebral nerve block with intra-needle and surface ultrasound

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

Paravertebral block

Intervention Type: PROCEDURE

Paravertebral block is the technique of injecting local anesthetic alongside the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen

Interventions

Intercostal nerve blocks

Intercostal nerve block is a regional anesthetic procedure for peri-operative pain management. It inhibits the action of the ipsilateral sensory and motor branches, and produces analgesic effects at the targeted thoracic level.

Intervention Type: PROCEDURE

Paravertebral block

Paravertebral block is the technique of injecting local anesthetic alongside the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen

Intervention Type: PROCEDURE

Other Intervention Names

ICNB; PVB

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FU-WEI SU, MD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Taiwan, R.o.c., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

FU-WEI SU, MD

Role: CONTACT

fuwei.su@gmail.com

+886-926037653

Hui-Hua Chiang, Ph.D

Role: CONTACT

hkennychiang3@gmail.com

+886-988293339

Facility Contacts

FU-WEI SU, MD

Role: primary

fuwei.su@gmail.com

+886-926037653

Other Identifiers

2020-04-003B

Identifier Type: -

Identifier Source: org_study_id