Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery (VERITAS)
Primary Purpose
Thoracic Surgery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Regional anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Surgery focused on measuring Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia
Eligibility 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
Sites / Locations
- Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
thoracic epidural analgesia
paravertebral block
Arm Description
A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.
A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.
Outcomes
Primary Outcome Measures
Opiate consumption
intraoperative opiate consumption
Secondary Outcome Measures
pain score
Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher NRS score indicates a worse outcome.
postoperative pain
cumulative dose of postoperatively given pain medication
anaesthetic depth
Bispectral Index
intraoperative nociception
Nociception Level (NOL)
Patient recovery
Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome
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)
Full Information
NCT ID
NCT05208619
First Posted
December 9, 2021
Last Updated
August 8, 2022
Sponsor
University Hospital, Bonn
Collaborators
HELIOS Klinikum Bonn/Rhein-Sieg
1. Study Identification
Unique Protocol Identification Number
NCT05208619
Brief Title
Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
Acronym
VERITAS
Official Title
Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 9, 2022 (Anticipated)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
Collaborators
HELIOS Klinikum Bonn/Rhein-Sieg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery
Keywords
Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
thoracic epidural analgesia
Arm Type
Active Comparator
Arm Description
A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.
Arm Title
paravertebral block
Arm Type
Active Comparator
Arm Description
A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
Regional anaesthesia
Intervention Description
Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery
Primary Outcome Measure Information:
Title
Opiate consumption
Description
intraoperative opiate consumption
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
pain score
Description
Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher NRS score indicates a worse outcome.
Time Frame
from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission)
Title
postoperative pain
Description
cumulative dose of postoperatively given pain medication
Time Frame
up to day 2 after surgery
Title
anaesthetic depth
Description
Bispectral Index
Time Frame
intraoperative
Title
intraoperative nociception
Description
Nociception Level (NOL)
Time Frame
intraoperative
Title
Patient recovery
Description
Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome
Time Frame
at day 1 after surgery
Title
Patient satisfaction
Description
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)
Time Frame
at day 2 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Soehle, MD, PhD, MHBA
Phone
++49-228-287-14127
Email
martin.soehle@ukbonn.de
Facility Information:
Facility Name
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Soehle, MD, PhD
Phone
++49-228-287
Ext
14127
Email
martin.soehle@ukbonn.de
First Name & Middle Initial & Last Name & Degree
Martin Soehle, MD, PhD, MHBA
First Name & Middle Initial & Last Name & Degree
Marcus Thudium, MD
First Name & Middle Initial & Last Name & Degree
Joachim Schmidt, MD, PhD
First Name & Middle Initial & Last Name & Degree
Donatas Zalepugas, MD
First Name & Middle Initial & Last Name & Degree
Claudia Neumann, MD
First Name & Middle Initial & Last Name & Degree
Philipp Niebel, MD
First Name & Middle Initial & Last Name & Degree
Philipp Schnorr, MD
First Name & Middle Initial & Last Name & Degree
Markus Brüggemann
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
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