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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04726930
Other study ID # 2020-04-003B
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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