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

University Hospital Bonn (UKB)

Status: Enrolling

Conditions: Thoracic Surgery

Treatments: Procedure: Regional anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05208619

Veritas

Details and patient eligibility

About

The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups

thoracic epidural analgesia

Active Comparator group

Description:

A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.

Treatment:

Procedure: Regional anaesthesia

paravertebral block

Active Comparator group

Description:

A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.

Treatment:

Procedure: Regional anaesthesia