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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper abdominal, or breast surgeries will be invited to join this trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FU-WEI SU, MD | Contact | +886-926037653 | fuwei.su@gmail.com | |
| Hui-Hua Chiang, Ph.D | Contact | +886-988293339 | hkennychiang3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| FU-WEI SU, MD | Taipei Veterans General Hospital, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan, R.o.c. | 11217 | Taiwan |
Sharing individual participant data that underlie the results reported in future publication, after de-identification ( text, tables, figures)
three months following article publication
Researchers who provide a methodologically sound proposal and receive the authors consent.
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| 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 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059265 | Visceral Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059226 | Nociceptive Pain |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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