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

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

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: Regional anaesthesia

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 Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Soehle, MD, PhD, MHBA; Phone Number: ++49-228-287-14127; Email: martin.soehle@ukbonn.de

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
    • Sub-Investigator: Marcus Thudium, MD
    • Contact: Martin Soehle, MD, PhD; Phone Number: 14127 ++49-228-287; Email: martin.soehle@ukbonn.de
    • Principal Investigator: Martin Soehle, MD, PhD, MHBA
    • Sub-Investigator: Joachim Schmidt, MD, PhD
    • Sub-Investigator: Donatas Zalepugas, MD
    • Sub-Investigator: Claudia Neumann, MD
    • Sub-Investigator: Philipp Niebel, MD
    • Sub-Investigator: Philipp Schnorr, MD
    • Sub-Investigator: Markus Brüggemann
  • Bonn, Germany, 53127
    • Recruiting
    • Helios Klinikum Bonn/Rhein-Sieg
    • Contact: Joachim Schmidt, MD, PhD; Phone Number: ++49-228-6481-11297; Email: Joachim.Schmidt@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Collaborators: HELIOS Klinikum Bonn/Rhein-Sieg

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: epidural analgesia; Thoracic surgery; paravertebral block; Thoracic anaesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Pain, Postoperative; Aortic Dissection; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Veritas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No