- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03890640
Ultrasound-assisted Thoracic Epidural Catheter Insertion
Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter.
Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Seoul, Corée, République de, 05505
- Asan Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients who will undergo upper abdomen or thoracic surgery
- Scheduled for thoracic epidural catheter insertion
- 20 ≤ age <80
- When obtaining informed consent voluntarily
Exclusion Criteria:
- Allergy to local anesthetics and contrast dye, and steroid
- Use of anticoagulants or antiplatelet medication, coagulopathy
- Infection at the insertion site
- Neurological or psychiatric disorders
- Prior spine instrumentation
- Pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Ultrasound-guided TECI
After assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
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When performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access.
All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline.
If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Success rate of ultrasound-guided thoracic epidural catheter insertion
Délai: on the day of the procedure
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Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.
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on the day of the procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of skin punctures
Délai: on the day of the procedure
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complete needle withdrawal from the skin and reinsertion at a new location
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on the day of the procedure
|
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Number of needle passes
Délai: on the day of the procedure
|
First needle pass + additional needle passes (the needle returned to a plane perpendicular to the skin before reinsertion.
Needle tip maneuvers toward the midline and cephalad were considered standard needle walking technique and were counted as a single pass)
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on the day of the procedure
|
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First attempt success rate
Délai: on the day of the procedure
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only first needle pass and first skin puncture
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on the day of the procedure
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jong-Hyuk Lee, MD, Asan Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019-0320
Informations sur les médicaments et les dispositifs, documents d'étude
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