Thorax; Pain, Spine, With Radicular and Visceral PainNCT04726930
Ultrasound Needle Transducer for Regional Anesthesia Validation Study
An observational study of Thorax; Pain, Spine, With Radicular and Visceral Pain and Acute Post-thoracotomy Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thorax; Pain, Spine, With Radicular and Visceral Pain, Acute Post-thoracotomy Pain, Pain, Postoperative
- What is being tested?
- Intercostal nerve blocks and Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2020to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper abdominal, or breast surgeries will be invited to join this trial.
Who may be able to join
- Patients scheduled for elective thoracic surgery
- Patients scheduled for elective upper abdominal surgery
- Patients scheduled for elective breast surgeries.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan, R.o.c., 11217
FU-WEI SU, MD, +886-926037653, fuwei.su@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Intercostal nerve blocks, Paravertebral block
- Keywords
- Intercostal nerve block, Paravertebral block, Ultrasound-guided pain intervention, Thoracic surgery, Breast surgery, Abdominal surgery, Ultrasound-guided peripheral nerve block, Postoperative pain
- Medical subject headings
- Pain, Visceral Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal nerve blocksProcedure or surgery
Also called ICNB
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 blockProcedure or surgery
Also called PVB
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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 Receives: Procedure: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needling time
Needle insertion to needle withdrawal (minutes)
Measured: 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
Measured: 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.
Measured: 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
Measured: During block procedure, up to 60 minutes.
Secondary outcomes (1)
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.
Measured: 20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Dec 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thorax; Pain, Spine, With Radicular and Visceral PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- FU-WEI SU, MD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726930
- Sponsor's protocol ID
- 2020-04-003B
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing individual participant data that underlie the results reported in future publication, after de-identification ( text, tables, figures)
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study
- ClinicalTrials.gov ID
- NCT04726930
- Acronym / sponsor ID
- 2020-04-003B
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intercostal nerve block with surface ultrasound | – | Procedure: Intercostal nerve blocksNumber 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 |
| Paravertebral block with surface ultrasound | – | Procedure: Paravertebral blockNumber 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. |
| Intercostal nerve block with intra-needle and surface ultrasound | – | Procedure: Intercostal nerve blocksNumber 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 |
| Paravertebral nerve block with intra-needle and surface ultrasound | – | Procedure: Paravertebral blockNumber 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper abdominal, or breast surgeries will be invited to join this trial.
Key inclusion criteria (3 listed)
- Patients scheduled for elective thoracic surgery
- Patients scheduled for elective upper abdominal surgery
- Patients scheduled for elective breast surgeries.
Key exclusion criteria (7 listed)
- Known coagulopathies,
- Skin lesion or infection at site of nerve block
- Pregnant women
- Allergic to local anesthetics
- Cognitive diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intercostal nerve blocksAlso: ICNBIntercostal 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. | Procedure or surgery | Intercostal nerve block with intra-needle and surface ultrasound, Intercostal nerve block with surface ultrasound |
| Paravertebral blockAlso: PVBParavertebral 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 | Procedure or surgery | Paravertebral block with surface ultrasound, Paravertebral nerve block with intra-needle and surface ultrasound |
Primary outcome
Needling time
Time frame: Needle insertion to needle withdrawal, up to 20 minutes
Needle insertion to needle withdrawal (minutes)
Nerve block procedure time
Time frame: Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal
Success rate of blockade
Time frame: 20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration)
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.
Visibility of needle tip and anatomic structure
Time frame: During block procedure, up to 60 minutes.
Record the visibility of needle tip, intercostal muscle, superior costotransverse ligament, pleura. Assessed by the inserting anesthetist on a 5 point Likert scale
1 secondary outcome
Inadvertent pleural puncture or pneumothorax
Time frame: 20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Yes. Sharing individual participant data that underlie the results reported in future publication, after de-identification ( text, tables, figures)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FU-WEI SU, MD study chair
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thorax; Pain, Spine, With Radicular and Visceral Pain and Acute Post-thoracotomy Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FU-WEI SU, MD (+886-926037653, fuwei.su@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needling time (time frame: Needle insertion to needle withdrawal, up to 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.