Anesthesia Clinical Trial
Official title:
Optical Tissue Stylet (OTS) - Descriptive Observational Study Into Paravertebral Space (PS) Detection in Humans
For effective anesthesia and interventional pain treatments, correct needle placement is
crucial. Currently used methods to guide needle placement and confirm the actual treatment
location before injection of the medication include: image-guidance, loss-of-resistance, and
electrical stimulation. However, accuracy of needle placement could be improved if
information would be available that would complement the current methods. We have developed
the so-called "photonic needle" technology based on optical spectroscopy that has the
potential to provide such complementary information.
This study is an observational study in a limited number of patients. A common
ultrasound-guided regional anesthesia procedure has been selected, during which data will be
acquired with the photonic needles at a number of points along the needle trajectory that
allow for confirmation by imaging.
Rationale for this study is to investigate the potential of the technology to discriminate
tissues that are relevant to distinguish during the procedure.
The primary objective of the trial is to investigate if the photonic needle technology can
reliably identify the thoracic paravertebral space. Diffuse reflectance spectra will be
acquired during needle advancement, with custom-made needle stylets that contain optical
fibers.
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 epinephrineOther study parameters
The endpoint of the study is a statistical analysis of the difference between diffuse
reflectance spectra obtained at non-paravertebral and paravertebral measurement locations.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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