Validation of a new ultrasound needle for regional anesthesia
High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study
This study is testing a new mini ultrasound needle to see if it can help doctors place anesthesia more accurately for patients having chest and upper belly surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei city, Taiwan, R.o.c.) |
| Trial ID | NCT04726930 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the efficacy of a miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia techniques, specifically paravertebral and intercostal nerve blocks. These procedures are essential for pain management in patients undergoing thoracic and upper abdominal surgeries. The study will investigate the feasibility and image quality of the intra-needle ultrasound system, which is designed to enhance the accuracy of needle placement and reduce complications associated with traditional ultrasound guidance. The study has received approval from the relevant institutional review board and health authorities in Taiwan.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective thoracic, upper abdominal, or breast surgeries.
Not a fit: Patients with known coagulopathies, skin infections at the block site, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for patients undergoing thoracic and upper abdominal surgeries.
How similar studies have performed: Other studies have shown promise in improving ultrasound-guided nerve blocks, but the specific use of an intra-needle ultrasound system is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Taipei city, Taiwan, R.o.c.
- Taipei Veterans General Hospital — Taipei city, Taiwan, R.o.c., Taiwan (Recruiting)
Study contacts
- Study coordinator: Fu-Wei Su, Md
- Email: fuwei.su@gmail.com
- Phone: +886-926037653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.