Optical Tissue Stylet - descriptive observational study into paravertebral space detection in humans

Completed

Conditions: correct needle placement
10009720

Registration Number: NL-OMON35212

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

Elective unilateral thoracic surgery
Age between 18 and 80 years of age
Ability and willingness to provide informed consent

Exclusion Criteria

Pregnancy
Photodynamic therapy
Contraindications to regional anesthesia and/or allergy to amide local anesthetics.
Subjects < 18 years of age or >80 years of age
Severe coagulopathy
Subjects with severe thoracic deformities

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are:<br /><br>1. Successfully acquired diffuse reflectance spectra obtained in the thoracic<br /><br>paravertebral space, and spectra obtained during needle advancement.<br /><br>2. Confirmation of sonographic thoracic paravertebral localization, defined as<br /><br>tissue imaging in all locations of the needle where the diffuse reflectance<br /><br>spectra have been collected .<br /><br>3. Recordings of reaction to a small test dose of lidocaine 2% with epinephrine<br /><br>1:200.000 at target position for regional anesthesia (to exclude vascular<br /><br>localization of the needle)<br /><br>4. certainty score on a 3-point scale (1 = uncertain, 2 = certain, 3 = very<br /><br>certain) provided by the physician for assignment of the type of tissue present<br /><br>at the needle tip, based on the information available from imaging and/or<br /><br>aspiration and/or reaction to a small injection of epinephrine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Methylene blue will be injected after the administration of local anesthetic.<br /><br>Subsequently, an additional confirmation of correct needle placement within the<br /><br>paravertebral space will be obtained by direct visual observation of the dye in<br /><br>the thoracic paravertebral space by the thoracic surgeron during surgery.</p><br>