Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Procedure: Regional anaesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thoracic epidural analgesia<br>A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter. | Procedure: Regional anaesthesia<br>* Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery<br>|
| Active Comparator: paravertebral block<br>A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia. | Procedure: Regional anaesthesia<br>* Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate consumption | intraoperative opiate consumption | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia