correct needle placement
Conditions
Interventions
None listed
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Elective unilateral thoracic surgery Age between 18 and 80 years of age Ability and willingness to provide informed consent
Exclusion criteria
Exclusion criteria: Pregnancy Photodynamic therapy Contraindications to regional anesthesia and/or allergy to amide local anesthetics. Subjects 80 years of age Severe coagulopathy Subjects with severe thoracic deformities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are: 1. Successfully acquired diffuse reflectance spectra obtained in the thoracic paravertebral space, and spectra obtained during needle advancement. 2. Confirmation of sonographic thoracic paravertebral localization, defined as tissue imaging in all locations of the needle where the diffuse reflectance spectra have been collected . 3. Recordings of reaction to a small test dose of lidocaine 2% with epinephrine 1:200.000 at target position for regional anesthesia (to exclude vascular localization of the needle) 4. *certainty score* on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging and/or aspiration and/or reaction to a small injection of epinephrine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Methylene blue will be injected after the administration of local anesthetic. Subsequently, an additional confirmation of correct needle placement within the paravertebral space will be obtained by direct visual observation of the dye in the thoracic paravertebral space by the thoracic surgeron during surgery. | — |
Countries
Netherlands
Outcome results
None listed