Photonic Needle and Paravertebral Space Detection (OTS-PS)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: thoracic surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia

Description

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
• Subjects with contraindications to methylene blue

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
paravertebral anesthesia; patients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia	Procedure: thoracic surgery; unilateral thoracic surgery under paravertebral block and general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the thoracic paravertebral space	Statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations	Day 0

Collaborators and Investigators

• Sponsor: Philips Healthcare
• Collaborators: Radboud University Medical Center
• Investigators: Principal Investigator: Gert-Jan Scheffer, PhD, MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: regional; paravertebral space; needle placement; tissue identification
• Other Study ID Numbers: NL37671.091.11