Acute Post-thoracotomy Pain, Pain, Postoperative, Thorax; Pain, Spine, With Radicular and Visceral Pain, Ultrasound Therapy; Complications
Conditions
Keywords
Intercostal nerve block, Paravertebral block, Ultrasound-guided pain intervention, Thoracic surgery, Breast surgery, Abdominal surgery, Ultrasound-guided peripheral nerve block, Postoperative pain
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.
Interventions
PROCEDUREIntercostal nerve blocks
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.
PROCEDUREParavertebral block
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
Sponsors
National Yang Ming Chiao Tung University
Taipei Veterans General Hospital, Taiwan
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needling time | Needle insertion to needle withdrawal, up to 20 minutes | Needle insertion to needle withdrawal (minutes) |
| Nerve block procedure time | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inadvertent pleural puncture or pneumothorax | 20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope) | Calculate the rate of Inadvertent pleural puncture or pneumothorax, defined by image evidence of pleura injuries or pneumothorax by thoracoscope, X-ray, or CT. |
Countries
Taiwan
Contacts
Primary ContactFU-WEI SU, MD
Backup ContactHui-Hua Chiang, Ph.D
Outcome results
None listed