Thoracic epidural or paravertebral analgesia after thoracic surgery
| ISRCTN | ISRCTN55650235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55650235 |
| Secondary identifying numbers | 40/10 |
- Submission date
- 11/04/2013
- Registration date
- 21/06/2013
- Last edited
- 21/06/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
We are carrying out a study on patients undergoing thoracic surgery. Inadequate pain treatment after surgery may lead to worsening of lung function because patients may find it difficult to take deep breaths. Standard procedures to reduce pain include thoracic epidural analgesia (TEA) and thoracic paravertebral analgesia (PVB). In principal, TEA can be expected to influence both sides of the thorax, whereas PVB is expected to block only the site of the operation. Our goal is to find out, whether this difference may affect the ability to breathe.
Who can participate?
Patients undergoing thoracic surgery.
What does the study involve?
Patients will be randomly allocated to two groups. One will receive the TEA and the other group PVB. Both procedures are standard pain treatment procedures in our institution. In addition, specialized pain nurses will take care of the appropriate treatment.
The lung function will be assessed by spirometry. The patient is asked to take a deep breath and then exhale into the sensor for as long as possible. The pain levels at rest and during coughing will also be assessed at regular intervals.
What are the possible benefits and risks of participating?
All participants will receive an additional teaching session regarding the pain measures and spirometry. Information obtained from this study may benefit future patient treatment.
By taking part in this study there are no extra risks of physical injury or harm.
Where is the study run from?
Saarland University Medical Center and Saarland University Faculty of Medicine, Homburg, Germany
When is the study starting and how long is it expected to run for?
The study runs from May 2010 to September 2013.
Who is funding the study?
Saarland University Faculty of Medicine, Homburg, Germany
Who is the main contact?
Prof. Dr. Thomas Volk
Thomas.volk@uks.eu
Contact information
Scientific
Saarland University Medical Center
and Saarland University Faculty of Medicine
Homburg
66421
Germany
Study information
| Study design | Randomised unicentric trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Thoracic Epidural or ParaVerteBral Analgesia after thoracic surgery: a randomised controlled trial |
| Study acronym | TEA vs PVB |
| Study objectives | Lung function after surgery, as measured by forced expiratory volume in 1 second (FeV1) and peak expiratory flow (PEF) is better when a continuous paravertebral catheter is used compared to a continuous thoracic epidural catheter. |
| Ethics approval(s) | Ethic committee of Auml;rztekammer Saarland, Nr.: 40/10, approved: April 2010 |
| Health condition(s) or problem(s) studied | Thoracic surgery |
| Intervention | Continuous thoracic epidural catheter or continuous paravertebral catheter for pain treatment |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | FV1 measured in L/sec and PEF measured in L/sec- lung function parameters from spirometry (FeV1=expiratory flow after 1 second, PEF=peak expiratory flow, FVC=forced vital capacity). The outcome parameters will be measured before the TEA or PVB placement, 15 minutes afterwards and twice daily until day 3 after surgery. |
| Secondary outcome measures | 1. Pain levels at rest and with coughing (using the verbal numeric rating scale at rest and during coughing) 2. Aggregated incidence of nausea, vomiting, pneumonia, atelectases 3. Mobilisation (time to stand up, to walk) The outcome parameters will be measured before the TEA or PVB placement, 15 minutes afterwards and twice daily until day 3 after surgery. |
| Overall study start date | 01/01/2012 |
| Completion date | 30/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 74 |
| Key inclusion criteria | 1. Aged 18 years old and above 2. American Society of Anesthesiologists (ASA) grade I-III 3. Planned thoracic surgery 4. Accepted procedure |
| Key exclusion criteria | 1. Relevant liver or renal disease (Kreatinin > 2 mg/dl, Bilirubin > 2 mg/dl) 2. Inability to communicate 3. Relevant cardiac or neurological disease 4. Chronic treatment with opioids or psychiatric drugs 5. Dependencies 6. Body Mass Index > 30 7. ASA > III 8. Contraindication for a neuraxial procedure |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 30/07/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
66421
Germany
Sponsor information
Hospital/treatment centre
c/o Prof. Dr. T. Volk
Homburg
66421
Germany
| Website | http://www.uniklinikum-saarland.de/ |
|---|---|
"ROR" |
https://ror.org/01jdpyv68 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
