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| Name | Class |
|---|---|
| HELIOS Klinikum Bonn/Rhein-Sieg | UNKNOWN |
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The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery
Thoracic interventions (lung operations) are associated with considerable postoperative pain, whereby an open surgical procedure via a skin incision (thoracotomy) is more painful than a minimally invasive endoscopic intervention (thoracoscopy). In order to reduce pain, a regional anaesthetic is administered during the induction of anaesthesia, which reduces pain both intraoperatively and postoperatively. In thoracic surgery, thoracic epidural analgesia (PDA) and paravertebral block (PVB) are the main regional anaesthesiological measures used, although it is unclear which of the two procedures is superior in terms of efficiency and effectiveness. Particularly intraoperatively, but also to some extent postoperatively, regional anaesthesia alone is usually not sufficient for pain management. Rather, additional systemic (i.e. intravenous) analgesics (especially opioids) are administered. Therefore, the amount of these additionally administered analgesics is a measure of the efficiency of the regional anaesthesia procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thoracic epidural analgesia | Active Comparator | A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter. |
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| paravertebral block | Active Comparator | A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional anaesthesia | Procedure | Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate consumption | intraoperative opiate consumption | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| pain score | Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher NRS score indicates a worse outcome. | from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission) |
| postoperative pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Soehle, MD, PhD, MHBA | Contact | ++49-228-287-14127 | martin.soehle@ukbonn.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn | Recruiting | Bonn | 53127 | Germany |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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cumulative dose of postoperatively given pain medication |
| up to day 2 after surgery |
| anaesthetic depth | Bispectral Index | intraoperative |
| intraoperative nociception | Nociception Level (NOL) | intraoperative |
| Patient recovery | Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome | at day 1 after surgery |
| Patient satisfaction | Bauer Satisfaction Questionnaire, consisting of 10 questions on anaesthesia-related discomfort (with 3 answer options: No/ Yes, moderate/ Yes, severe) and 5 questions on satisfaction with anaesthesia care (with 4 answer options: very satisfied/ satisfied / dissatisfied/ very dissatisfied) | at day 2 after surgery |
| Helios Klinikum Bonn/Rhein-Sieg | Recruiting | Bonn | 53127 | Germany |
|