Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA, Netherlands
NCT Number: NCT01517386
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.
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Notify Me18 year–80 year
All sexes
Observational
Nijmegen, 6525 GA, Netherlands
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:
The endpoint of the study is a statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
unilateral thoracic surgery under paravertebral block and general anesthesia
Time frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations
Philips Healthcare
Industry
Optical Tissue Stylet (OTS) - Descriptive Observational Study Into Paravertebral Space (PS) Detection in Humans
Acronym: OTS-PS
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