Ultrasound Needle Transducer for Regional Anesthesia Validation Study

NCT04726930 | Unknown DMC

• 1 other identifier: 2020-04-003B
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Intercostal nerve block; Paravertebral block; Ultrasound-guided pain intervention; Thoracic surgery; Breast surgery; Abdominal surgery; Ultrasound-guided peripheral nerve block; Postoperative pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Inadvertent pleural puncture or pneumothorax

  20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)

Study Arms (4)

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

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

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

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

Interventions

Intercostal nerve blocks 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.

Also known as: ICNB

Intercostal nerve block with intra-needle and surface ultrasound; Intercostal nerve block with surface ultrasound

Paravertebral block 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

Also known as: PVB

Paravertebral block with surface ultrasound; Paravertebral nerve block with intra-needle and surface ultrasound

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients scheduled for elective thoracic surgery
• Patients scheduled for elective upper abdominal surgery
• Patients scheduled for elective breast surgeries.

You may not qualify if:

• Known coagulopathies,
• Skin lesion or infection at site of nerve block
• Pregnant women
• Allergic to local anesthetics
• Cognitive diseases
• Unstable hemodynamics
• Chronic substance abuse (ex. alcohol, hypnotics, opioids)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

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

RECRUITING

MeSH Terms

Conditions

Pain; Visceral Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Postoperative Complications; Pathologic Processes

Study Officials

• FU-WEI SU, MD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

FU-WEI SU, MD

CONTACT

+886-926037653; fuwei.su@gmail.com

Hui-Hua Chiang, Ph.D

CONTACT

+886-988293339; hkennychiang3@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 27, 2021
• Study Start: December 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 1, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: three months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and receive the authors consent.

Locations

TW (1)