No registrations found.
ID
Source
Brief title
Health condition
regional anesthesia
needle placement
paravertebral space
Sponsors and support
Department of Anesthesiology
P.O. Box 9101
6500 HB Nijmegen
+31 (0)24 3611111
Intervention
Outcome measures
Primary outcome
This is an observational study. No outcome is measured.
Secondary outcome
This is an observational study. No outcome is measured.
Background summary
The primary objective of the trial is to investigate if the optical tissue stylet 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. The study takes place at the Radboud University Medical Centre in Nijmegen, The Netherlands. All patients are recruited in the Netherlands.
Study objective
The primary objective of the trial is to investigate if the optical tissue stylet 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.
Study design
Measurements and observations take place during the procedure and subsequent surgery. No follow-up is required for this study.
Intervention
A stylet equipped with optical fibers is used to collect data during routine performance of paravertebral blocks for elective surgery. In addition, methylene blue will be injected to confirm paravertebral needle placement during surgery.
Inclusion criteria
1. Elective unilateral thoracic surgery;
2. Age between 18 and 80 years of age;
3. Male and female subjects;
4. Ability and willingness to provide informed consent.
Exclusion criteria
1. Pregnancy;
2. Photodynamic therapy;
3. Contraindications to regional anesthesia and/or allergy to amide local anesthetics;
4. Subjects < 18 years of age or >80 years of age;
5. Severe coagulopathy;
6. Subjects with severe thoracic deformities;
7. Subjects with contraindications to methylene blue.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3098 |
| NTR-old | NTR3238 |
| CCMO | NL37671.091.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35212 |