Clinical trial NCT04726930: Ultrasound Needle Transducer for Regional Anesthesia Validation Study
Official title: High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2021-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper abdominal, or breast surgeries will be invited to join this trial.

Brief summary: 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.

Eligibility 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)

Primary outcomes:
measure: Needling time
timeFrame: Needle insertion to needle withdrawal, up to 20 minutes
measure: Nerve block procedure time
timeFrame: Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
measure: Success rate of blockade
timeFrame: 20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration)
measure: Visibility of needle tip and anatomic structure
timeFrame: During block procedure, up to 60 minutes.
Secondary outcomes:
measure: Inadvertent pleural puncture or pneumothorax
timeFrame: 20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taiwan, R.o.c.
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: FU-WEI SU, MD
role: STUDY_CHAIR
References: