Photonic Needle and Paravertebral Space Detection

NCT01517386 | Completed

• 1 other identifier: NL37671.091.11
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Keywords

paravertebral space; needle placement; tissue identification; regional

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

paravertebral anesthesia

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

Procedure: thoracic surgery

Interventions

thoracic surgery PROCEDURE

unilateral thoracic surgery under paravertebral block and general anesthesia

paravertebral anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Healthcare: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6525 GA, Netherlands

Location

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Gert-Jan Scheffer, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-07

Locations

NL (1)