Pain, Postoperative Clinical Trial
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.
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) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei city | Taiwan, R.o.c. |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan | National Yang Ming University |
Taiwan,
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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