History of Changes for Study: NCT05208619

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

Latest version (submitted November 21, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	January 25, 2022	None (earliest Version on record)
2	January 31, 2022	Study Status and Oversight
3	August 8, 2022	Study Status
4	November 21, 2023	Recruitment Status, Study Status and Contacts/Locations

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Study NCT05208619
Submitted Date: January 31, 2022 (v2)

Study Identification


Unique Protocol ID:	Veritas
Brief Title:	Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery (VERITAS)
Official Title:	Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
Secondary IDs:

Study Status


Record Verification:	January 2022
Overall Status:	Not yet recruiting
Study Start:	February 15, 2022
Primary Completion:	January 15, 2023 [Anticipated]
Study Completion:	April 30, 2023 [Anticipated]

First Submitted:	December 9, 2021
First Submitted that Met QC Criteria:	January 25, 2022
First Posted:	January 26, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	January 31, 2022
Last Update Posted:	February 15, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	University Hospital, Bonn
Responsible Party:	Principal Investigator Investigator: Martin Soehle Official Title: Vice Head of Department Affiliation: University Hospital, Bonn
Collaborators:	HELIOS Klinikum Bonn/Rhein-Sieg

Study Description

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.

Conditions


Conditions:	Thoracic Surgery
Keywords:	Thoracic surgery paravertebral block epidural analgesia Thoracic anaesthesia

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	118 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


Primary Outcome Measures:
1.	Opiate consumption [ Time Frame: intraoperative ] intraoperative opiate consumption
Secondary Outcome Measures:
1.	pain score [ Time Frame: 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.
2.	postoperative pain [ Time Frame: up to day 2 after surgery ] cumulative dose of postoperatively given pain medication
3.	anaesthetic depth [ Time Frame: intraoperative ] Bispectral Index
4.	intraoperative nociception [ Time Frame: intraoperative ] Nociception Level (NOL)
5.	Patient recovery [ Time Frame: at day 1 after surgery ] Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome
6.	Patient satisfaction [ Time Frame: 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)

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

Contacts/Locations


Central Contact Person:	Martin Soehle, MD, PhD, MHBA Telephone: ++49-228-287-14127 Email: martin.soehle@ukbonn.de
Locations:	Germany
	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn Bonn, Germany, 53127 Contact:Contact: Martin Soehle, MD, PhD ++49-228-287 Ext. 14127 martin.soehle@ukbonn.de Contact:Principal Investigator: Martin Soehle, MD, PhD, MHBA Contact:Sub-Investigator: Marcus Thudium, MD Contact:Sub-Investigator: Joachim Schmidt, MD, PhD Contact:Sub-Investigator: Donatas Zalepugas, MD Contact:Sub-Investigator: Claudia Neumann, MD Contact:Sub-Investigator: Philipp Niebel, MD Contact:Sub-Investigator: Philipp Schnorr, MD Contact:Sub-Investigator: Markus Brüggemann

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