Condition category
Surgery
Date applied
11/04/2013
Date assigned
21/06/2013
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Thomas Volk

ORCID ID

Contact details

Saarland University Medical Center
and Saarland University Faculty of Medicine
Homburg
66421
Germany

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

http://www.uniklinikum-saarland.de/

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

Publication citations

Additional files

Editorial Notes