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…
ID
Bron
Verkorte titel
Aandoening
regional anesthesia
needle placement
paravertebral space
Ondersteuning
Department of Anesthesiology
P.O. Box 9101
6500 HB Nijmegen
+31 (0)24 3611111
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
This is an observational study. No outcome is measured.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Measurements and observations take place during the procedure and subsequent surgery. No follow-up is required for this study.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3098 |
| NTR-old | NTR3238 |
| CCMO | NL37671.091.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35212 |