ThoracotomyNCT01076894
Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia
A study testing epidural anesthesia and intercostal anesthesia in people with Thoracotomy, run by University of Ulm at 1 site in Germany.
Trial summary
Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracotomy
- What is being tested?
- epidural anesthesia and intercostal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Oct 2009
- 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
- patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection
Who cannot join
- age<18 yr
- any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac
- lack of patient's cooperation
- any type of chronic painful condition or current opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.
Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.
Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary
- Conditions
- Thoracotomy
- Being tested
- epidural anesthesia, intercostal anesthesia
- Keywords
- pain, thoracotomy, pulmonary function, epidural anesthesia, intercostal nerve block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaProcedure or surgery
In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.
intercostal anesthesiaProcedure or surgery
In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits
| Study group | Role | What they receive |
|---|---|---|
| epidural anesthesia | Active comparator | Not described Receives: Procedure: epidural anesthesia |
| intercostal anesthesia | Active comparator | Not described Receives: Procedure: intercostal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at rest and on coughing after thoracic surgery
Measured: Pain during the first four postoperative days
Secondary outcomes (1)
pulmonary function (peak expiratory flow rate) after thoracic surgery
Measured: first four postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies 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
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Michael Georgieff, Prof., Study chair, Department for Anesthesiology University Clinic Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076894
- Sponsor's protocol ID
- EDA-ICB 198/06
- Status last verified
- Feb 2010
- First submitted
- 25 Feb 2010
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT01076894
- Acronym / sponsor ID
- EDA-ICB 198/06
- Conditions
- Thoracotomy
- Keywords
- pain, thoracotomy, pulmonary function, epidural anesthesia, intercostal nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Feb 2010 (estimated)
- 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.
Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.
Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural anesthesia | Active comparator | Procedure: epidural anesthesia |
| intercostal anesthesia | Active comparator | Procedure: intercostal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection
Key exclusion criteria (4 listed)
- age<18 yr
- any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac
- lack of patient's cooperation
- any type of chronic painful condition or current opioid use
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 |
|---|---|---|
| epidural anesthesiaIn the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10. | Procedure or surgery | epidural anesthesia |
| intercostal anesthesiaIn the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits | Procedure or surgery | intercostal anesthesia |
Primary outcome
Pain at rest and on coughing after thoracic surgery
Time frame: Pain during the first four postoperative days
1 secondary outcome
pulmonary function (peak expiratory flow rate) after thoracic surgery
Time frame: first four postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
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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.
Michael Georgieff, Prof. study chair
Department for Anesthesiology University Clinic Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural anesthesia and intercostal anesthesia in people with Thoracotomy, run by University of Ulm at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest and on coughing after thoracic surgery (time frame: Pain during the first four postoperative days). 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 26 Feb 2010.