Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
40/10
Study information
Scientific title
Thoracic Epidural or ParaVerteBral Analgesia after thoracic surgery: a randomised controlled trial
Acronym
TEA vs PVB
Study hypothesis
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
Ethic committee of Auml;rztekammer Saarland, Nr.: 40/10, approved: April 2010
Study design
Randomised unicentric trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Thoracic surgery
Intervention
Continuous thoracic epidural catheter or continuous paravertebral catheter for pain treatment
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2012
Overall trial end date
30/07/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
74
Participant 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
Recruitment start date
01/01/2012
Recruitment end date
30/07/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Saarland University Medical Center
Homburg
66421
Germany
Sponsor information
Organisation
Saarland University Medical Center and Saarland University Faculty of Medicine (Germany)
Sponsor details
c/o Prof. Dr. T. Volk
Homburg
66421
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Saarland University Medical Center and Saarland University Faculty of Medicine (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary