Thoracic SurgeryVERITASNCT05208619
Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
A study testing Regional anaesthesia in people with Thoracic Surgery, run by University Hospital, Bonn at 2 sites in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Regional anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Aug 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective thoracic surgery
- American Society of Anaesthesiologists (ASA) 1-3 status
- written informed consent
Who cannot join
- pregnancy
- adipositas (bmi > 30)
- cardiac arrhythmia
- coagulation abnormalities
- chronic pain
- opiate abuses
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Bonn, 53127
Martin Soehle, MD, PhD, ++49-228-287 ext. 14127, martin.soehle@ukbonn.de
Martin Soehle, MD, PhD, MHBA
- Recruiting
Helios Klinikum Bonn/Rhein-Sieg
Bonn, 53127
Joachim Schmidt, MD, PhD, ++49-228-6481-11297, Joachim.Schmidt@helios-gesundheit.de
About this study
The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery
Read the 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
- Thoracic Surgery
- Being tested
- Regional anaesthesia
- Keywords
- Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anaesthesiaProcedure or surgery
Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural analgesia | Active comparator | A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter. Receives: Procedure: Regional anaesthesia |
| paravertebral block | Active comparator | A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia. Receives: Procedure: Regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate consumption
intraoperative opiate consumption
Measured: intraoperative
Secondary outcomes (6)
pain score
Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher NRS score indicates a worse outcome.
Measured: 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
Measured: up to day 2 after surgery
anaesthetic depth
Bispectral Index
Measured: intraoperative
intraoperative nociception
Nociception Level (NOL)
Measured: intraoperative
Patient recovery
Quality of Recovery Score (QoR-15) ranging from 0-150, with a higher value representing a better outcome
Measured: 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)
Measured: at day 2 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 Aug 2022
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- HELIOS Klinikum Bonn/Rhein-Sieg
- Responsible party
- Principal investigator, Martin Soehle, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208619
- Sponsor's protocol ID
- Veritas
- Acronym
- VERITAS
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05208619
- Acronym / sponsor ID
- VERITAS / Veritas
- Conditions
- Thoracic Surgery
- Keywords
- Thoracic surgery, paravertebral block, epidural analgesia, Thoracic anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- HELIOS Klinikum Bonn/Rhein-Sieg
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural analgesia | Active comparator | Procedure: Regional anaesthesiaA thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter. |
| paravertebral block | Active comparator | Procedure: Regional anaesthesiaA single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective thoracic surgery
- American Society of Anaesthesiologists (ASA) 1-3 status
- written informed consent
Key exclusion criteria (6 listed)
- pregnancy
- adipositas (bmi > 30)
- cardiac arrhythmia
- coagulation abnormalities
- chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional anaesthesiaPatients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery | Procedure or surgery | paravertebral block, thoracic epidural analgesia |
Primary outcome
Opiate consumption
Time frame: intraoperative
intraoperative opiate consumption
6 secondary outcomes
pain score
Time frame: from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission)
postoperative pain
Time frame: up to day 2 after surgery
anaesthetic depth
Time frame: intraoperative
intraoperative nociception
Time frame: intraoperative
Patient recovery
Time frame: at day 1 after surgery
Patient satisfaction
Time frame: at day 2 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anaesthesia in people with Thoracic Surgery, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Soehle, MD, PhD, MHBA (++49-228-287-14127, martin.soehle@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate consumption (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.