Ultrasound Needle Transducer for Regional Anesthesia Validation Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Ultrasound Therapy; Complications; Acute Post-thoracotomy Pain; Thorax; Pain, Spine, With Radicular and Visceral Pain
• Intervention / Treatment: Procedure: Intercostal nerve blocks; Procedure: Paravertebral block

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: FU-WEI SU, MD; Phone Number: +886-926037653; Email: fuwei.su@gmail.com
• Study Contact Backup: Name: Hui-Hua Chiang, Ph.D; Phone Number: +886-988293339; Email: hkennychiang3@gmail.com

Study Locations

• Taiwan
  • Taiwan, R.o.c.
    • Taipei city, Taiwan, R.o.c., Taiwan, 11217
      • Recruiting
      • Taipei Veterans General Hospital
      • Contact: FU-WEI SU, MD; Phone Number: +886-926037653; Email: fuwei.su@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper abdominal, or breast surgeries will be invited to join this trial.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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.; Other Names: ICNB
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.	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; Other Names: PVB
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	Procedure: 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.; Other Names: ICNB
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	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; Other Names: PVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needling time	Needle insertion to needle withdrawal (minutes)	Needle insertion to needle withdrawal, up to 20 minutes
Nerve block procedure time	How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal	Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
Success rate of blockade	Successful blockade will be determined by 1.ultrasound evidence of ideal spreading or 2.evidence of fluid accumulation around intercostal nerves or at paravertebral space under thoracoscope, or 3. loss of cold sensation on the chest or abdomen at block level.	20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration)
Visibility of needle tip and anatomic structure	Record the visibility of needle tip, intercostal muscle, superior costotransverse ligament, pleura. Assessed by the inserting anesthetist on a 5 point Likert scale	During block procedure, up to 60 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inadvertent pleural puncture or pneumothorax	Calculate the rate of Inadvertent pleural puncture or pneumothorax, defined by image evidence of pleura injuries or pneumothorax by thoracoscope, X-ray, or CT.	20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming University
• Investigators: Study Chair: FU-WEI SU, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative pain; Breast surgery; Thoracic surgery; Abdominal surgery; Paravertebral block; Intercostal nerve block; Ultrasound-guided pain intervention; Ultrasound-guided peripheral nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Nociceptive Pain; Pain, Postoperative; Visceral Pain
• Other Study ID Numbers: 2020-04-003B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing individual participant data that underlie the results reported in future publication, after de-identification ( text, tables, figures)
• IPD Sharing Time Frame: three months following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and receive the authors consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No