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

Thoracic Surgery Clinical Trial

— VERITAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208619
• Other study ID #: Veritas
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Bonn
• Contact: Martin Soehle, MD, PhD, MHBA
• Phone: ++49-228-287-14127
• Email: martin.soehle[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: April 30, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Pain, Postoperative
• Thoracic Surgery

Intervention

Procedure:
• Regional anaesthesia
Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Bonn
Germany	Helios Klinikum Bonn/Rhein-Sieg	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	HELIOS Klinikum Bonn/Rhein-Sieg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate consumption	intraoperative opiate consumption	intraoperative
Secondary	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)
Secondary	postoperative pain	cumulative dose of postoperatively given pain medication	up to day 2 after surgery
Secondary	anaesthetic depth	Bispectral Index	intraoperative
Secondary	intraoperative nociception	Nociception Level (NOL)	intraoperative
Secondary	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
Secondary	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