Thoracic Surgery
Conditions
Keywords
Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia
Brief summary
The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery
Detailed description
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.
Interventions
PROCEDURERegional anaesthesia
Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery
Sponsors
HELIOS Klinikum Bonn/Rhein-Sieg
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective thoracic surgery * American Society of Anaesthesiologists (ASA) 1-3 status * written informed consent
Exclusion criteria
* pregnancy * adipositas (bmi \> 30) * cardiac arrhythmia * coagulation abnormalities * chronic pain * opiate abuses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate consumption | intraoperative | intraoperative opiate consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | up to day 2 after surgery | cumulative dose of postoperatively given pain medication |
| anaesthetic depth | intraoperative | Bispectral Index |
| pain score | from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission) | Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher NRS score indicates a worse outcome. |
| Patient recovery | at day 1 after surgery | Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome |
| Patient satisfaction | at day 2 after surgery | 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) |
| intraoperative nociception | intraoperative | Nociception Level (NOL) |
Countries
Germany
Contacts
Primary ContactMartin Soehle, MD, PhD, MHBA
Outcome results
None listed