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

Not Applicable

Recruiting

• Conditions: Thoracic Surgery
• Interventions: Procedure: Regional anaesthesia

• Registration Number: NCT05208619
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Study Start: 2022-08-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-01-15
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paravertebral block	Regional anaesthesia	A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.
thoracic epidural analgesia	Regional anaesthesia	A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.

Primary Outcome Measures

Name	Time	Method
Opiate consumption	intraoperative	intraoperative opiate consumption

Secondary Outcome Measures

Name	Time	Method
postoperative pain	up to day 2 after surgery	cumulative dose of postoperatively given pain medication
anaesthetic depth	intraoperative	Bispectral Index
intraoperative nociception	intraoperative	Nociception Level (NOL)
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)
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.

Trial Locations

Locations (2)

Helios Klinikum Bonn/Rhein-Sieg; 🇩🇪 Bonn, Germany

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn; 🇩🇪 Bonn, Germany