Photonic Needle and Paravertebral Space Detection (OTS-PS)

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01517386
First received: January 20, 2012
Last updated: December 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Anesthesia
Procedure: thoracic surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Optical Tissue Stylet (OTS) - Descriptive Observational Study Into Paravertebral Space (PS) Detection in Humans

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Identification of the thoracic paravertebral space [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations


Enrollment: 10
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517386

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Philips Healthcare
Radboud University
Investigators
Principal Investigator: Gert-Jan Scheffer, PhD, MD Radboud University
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01517386     History of Changes
Other Study ID Numbers: NL37671.091.11
Study First Received: January 20, 2012
Last Updated: December 3, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Philips Healthcare:
paravertebral space
needle placement
tissue identification
regional

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014