Posterolateral ThoracotomyNCT01718717
Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF
A study testing Thoracic Epidural Analgesia (TEA) and TEA followed by Intravenous morphine in people with Posterolateral Thoracotomy and Lung Resection, run by Larissa University Hospital at 1 site in Greece.
Trial summary
Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce the occurrence of AF if it is continued for six postoperative days instead of just three. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Posterolateral Thoracotomy, Lung Resection, Thoracic Epidural Analgesia
- What is being tested?
- Thoracic Epidural Analgesia (TEA) and TEA followed by Intravenous morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2014to Jan 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung resection
- pneumonectomy
Who cannot join
- Patient refusal
- AF (present or in the past
- contraindications for epidural catheter placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis
Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce the occurrence of AF if it is continued for six postoperative days instead of just three.
Read the detailed description
THEA is considered a very effective technique of providing intra and post-operative analgesia for thoracic surgical procedure and it seems that can also be effective in reducing the incidence of postoperative AF in patients undergoing lung resection. Nevertheless the timing of stopping the epidural analgesia and its further substitution with other therapies, remains unclear.
In this study patients who are scheduled for lung resection surgery will undergo the surgery under combined general anesthesia with volatile anesthetics and thoracic epidural anesthesia.
Immediately after surgery the patients will be divided into two groups:
- those who will receive thoracic epidural analgesia for 6 days
- those who will receive thoracic epidural analgesia for 3 days and will then switch to intravenous morphine for another 3 days
All the patients will be monitored daily for arrythmias
- Conditions
- Posterolateral Thoracotomy, Lung Resection, Thoracic Epidural Analgesia, Sympathetic Outflow, Atrial Fibrillation
- Being tested
- Thoracic Epidural Analgesia (TEA), TEA followed by Intravenous morphine
- Keywords
- Thoracotomy, Thoracic epidural analgesia, Arrythmiogenesis, Atrial fibrillation, Sympathetic outflow
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Epidural Analgesia (TEA)Other
TEA followed by Intravenous morphineOther
| Study group | Role | What they receive |
|---|---|---|
| 6 days TEA | Active comparator | Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia Receives: Other: Thoracic Epidural Analgesia (TEA) |
| 3 days TEA and 3 days intravenous morphine | Active comparator | Postoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia Receives: Other: TEA followed by Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of AF
Every day, for the first 6 postoperative days, the investigators will record an ECG of the patient, and look after for any presence of AF
Measured: 6 postoperative days
Secondary outcomes (1)
Quality of analgesia
The investigators will record the quality of analgesia, as it can be measured with VAS, for the 6 first postoperative days for all patients
Measured: 6 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startDec 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Posterolateral 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metaxia Bareka, Larissa University Hospital
- Investigators
- Metaxia Bareka, Medicine, Principal investigator, Larissa University HospitalMarina Simaioforidou, Medicine, Study chair, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718717
- Sponsor's protocol ID
- TEA and AF
- Status last verified
- Jul 2014
- First submitted
- 28 Oct 2012
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
PubMed 11118174O'Higgins F, Tuckey JP. Thoracic epidural anaesthesia and analgesia: United Kingdom practice. Acta Anaesthesiol Scand. 2000 Oct;44(9):1087-92. doi: 10.1034/j.1399-6576.2000.440909.x.
PubMed 11028728Mendola C, Ferrante D, Oldani E, Cammarota G, Cecci G, Vaschetto R, Della Corte F. Thoracic epidural analgesia in post-thoracotomy patients: comparison of three different concentrations of levobupivacaine and sufentanil. Br J Anaesth. 2009 Mar;102(3):418-23. doi: 10.1093/bja/aep004. Epub 2009 Feb 3.
PubMed 19189982De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.
PubMed 18953284Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
PubMed 19307137Scarci M, Joshi A, Attia R. In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management? Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):92-6. doi: 10.1510/icvts.2009.221127. Epub 2009 Oct 23.
PubMed 19854794Shrivastava V, Nyawo B, Dunning J, Morritt G. Is there a role for prophylaxis against atrial fibrillation for patients undergoing lung surgery? Interact Cardiovasc Thorac Surg. 2004 Dec;3(4):656-62. doi: 10.1016/j.icvts.2004.08.002.
PubMed 17670334Oka T, Ozawa Y, Ohkubo Y. Thoracic epidural bupivacaine attenuates supraventricular tachyarrhythmias after pulmonary resection. Anesth Analg. 2001 Aug;93(2):253-9, 1st contents page. doi: 10.1097/00000539-200108000-00003.
PubMed 11473839Simeoforidou M, Vretzakis G, Bareka M, Chantzi E, Flossos A, Giannoukas A, Tsilimingas N. Thoracic epidural analgesia with levobupivacaine for 6 postoperative days attenuates sympathetic activation after thoracic surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):817-23. doi: 10.1053/j.jvca.2010.08.003. Epub 2010 Oct 13.
PubMed 20947382
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis
- ClinicalTrials.gov ID
- NCT01718717
- Acronym / sponsor ID
- TEA and AF
- Conditions
- Posterolateral Thoracotomy, Lung Resection, Thoracic Epidural Analgesia, Sympathetic Outflow, Atrial Fibrillation
- Keywords
- Thoracotomy, Thoracic epidural analgesia, Arrythmiogenesis, Atrial fibrillation, Sympathetic outflow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 31 Oct 2012 (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.
Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce the occurrence of AF if it is continued for six postoperative days instead of just three.
Detailed description
THEA is considered a very effective technique of providing intra and post-operative analgesia for thoracic surgical procedure and it seems that can also be effective in reducing the incidence of postoperative AF in patients undergoing lung resection. Nevertheless the timing of stopping the epidural analgesia and its further substitution with other therapies, remains unclear.
In this study patients who are scheduled for lung resection surgery will undergo the surgery under combined general anesthesia with volatile anesthetics and thoracic epidural anesthesia.
Immediately after surgery the patients will be divided into two groups:
- those who will receive thoracic epidural analgesia for 6 days
- those who will receive thoracic epidural analgesia for 3 days and will then switch to intravenous morphine for another 3 days
All the patients will be monitored daily for arrythmias
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 days TEA | Active comparator | Other: Thoracic Epidural Analgesia (TEA)Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia |
| 3 days TEA and 3 days intravenous morphine | Active comparator | Other: TEA followed by Intravenous morphinePostoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lung resection
- pneumonectomy
Key exclusion criteria (3 listed)
- Patient refusal
- AF (present or in the past
- contraindications for epidural catheter placement
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 |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) | Other | 6 days TEA |
| TEA followed by Intravenous morphine | Other | 3 days TEA and 3 days intravenous morphine |
Primary outcome
Occurrence of AF
Time frame: 6 postoperative days
Every day, for the first 6 postoperative days, the investigators will record an ECG of the patient, and look after for any presence of AF
1 secondary outcome
Quality of analgesia
Time frame: 6 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Background: PubMed 11118174Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Background: PubMed 11028728O'Higgins F, Tuckey JP. Thoracic epidural anaesthesia and analgesia: United Kingdom practice. Acta Anaesthesiol Scand. 2000 Oct;44(9):1087-92. doi: 10.1034/j.1399-6576.2000.440909.x.
- Background: PubMed 19189982Mendola C, Ferrante D, Oldani E, Cammarota G, Cecci G, Vaschetto R, Della Corte F. Thoracic epidural analgesia in post-thoracotomy patients: comparison of three different concentrations of levobupivacaine and sufentanil. Br J Anaesth. 2009 Mar;102(3):418-23. doi: 10.1093/bja/aep004. Epub 2009 Feb 3.
- Background: PubMed 18953284De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27.
- Background: PubMed 19307137Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
- Background: PubMed 19854794Scarci M, Joshi A, Attia R. In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management? Interact Cardiovasc Thorac Surg. 2010 Jan;10(1):92-6. doi: 10.1510/icvts.2009.221127. Epub 2009 Oct 23.
- Background: PubMed 17670334Shrivastava V, Nyawo B, Dunning J, Morritt G. Is there a role for prophylaxis against atrial fibrillation for patients undergoing lung surgery? Interact Cardiovasc Thorac Surg. 2004 Dec;3(4):656-62. doi: 10.1016/j.icvts.2004.08.002.
- Background: PubMed 11473839Oka T, Ozawa Y, Ohkubo Y. Thoracic epidural bupivacaine attenuates supraventricular tachyarrhythmias after pulmonary resection. Anesth Analg. 2001 Aug;93(2):253-9, 1st contents page. doi: 10.1097/00000539-200108000-00003.
- Background: PubMed 20947382Simeoforidou M, Vretzakis G, Bareka M, Chantzi E, Flossos A, Giannoukas A, Tsilimingas N. Thoracic epidural analgesia with levobupivacaine for 6 postoperative days attenuates sympathetic activation after thoracic surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):817-23. doi: 10.1053/j.jvca.2010.08.003. Epub 2010 Oct 13.
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.
Metaxia Bareka, Medicine principal investigator
Larissa University Hospital
Marina Simaioforidou, Medicine study chair
Larissa University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Epidural Analgesia (TEA) and TEA followed by Intravenous morphine in people with Posterolateral Thoracotomy and Lung Resection, run by Larissa University Hospital at 1 site in Greece.
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 2 inclusion and 3 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 10 Jul 2014. 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 Greece. 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 Metaxia Bareka, Medicine (00306947845083 ext. 1370, barekametaxia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of AF (time frame: 6 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718717, which also lists 9 linked publications.
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 10 Jul 2014.