Ultrasound Needle Transducer for Regional Anesthesia Validation Study

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726930
• Other study ID #: 2020-04-003B
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: FU-WEI SU, MD
• Phone: +886-926037653
• Email: fuwei.su[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city	Taiwan, R.o.c.

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needling time	Needle insertion to needle withdrawal (minutes)	Needle insertion to needle withdrawal, up to 20 minutes
Primary	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
Primary	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)
Primary	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	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)