Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF

NCT ID: NCT01718717

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Posterolateral Thoracotomy Lung Resection Thoracic Epidural Analgesia Sympathetic Outflow Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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6 days TEA

Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Analgesia (TEA)

Intervention Type OTHER

3 days TEA and 3 days intravenous morphine

Postoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia

Group Type ACTIVE_COMPARATOR

TEA followed by Intravenous morphine

Intervention Type OTHER

Interventions

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Thoracic Epidural Analgesia (TEA)

Intervention Type OTHER

TEA followed by Intravenous morphine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* lung resection
* pneumonectomy

Exclusion Criteria

* Patient refusal
* AF (present or in the past
* contraindications for epidural catheter placement
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Metaxia Bareka

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Metaxia Bareka, Medicine

Role: PRINCIPAL_INVESTIGATOR

Larissa University Hospital

Marina Simaioforidou, Medicine

Role: STUDY_CHAIR

Larissa University Hospital

Locations

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Larissa University Hospital

Larissa, Thessally, Greece

Site Status

Countries

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Greece

Central Contacts

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Metaxia Bareka, Medicine

Role: CONTACT

00306947845083 ext. 1370

Marina Simaioforidou, Medicine

Role: CONTACT

00306972202573 ext. 1370

References

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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.

Reference Type BACKGROUND
PMID: 11118174 (View on PubMed)

O'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.

Reference Type BACKGROUND
PMID: 11028728 (View on PubMed)

Mendola 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.

Reference Type BACKGROUND
PMID: 19189982 (View on PubMed)

De 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.

Reference Type BACKGROUND
PMID: 18953284 (View on PubMed)

Wildgaard 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.

Reference Type BACKGROUND
PMID: 19307137 (View on PubMed)

Scarci 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.

Reference Type BACKGROUND
PMID: 19854794 (View on PubMed)

Shrivastava 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.

Reference Type BACKGROUND
PMID: 17670334 (View on PubMed)

Oka 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.

Reference Type BACKGROUND
PMID: 11473839 (View on PubMed)

Simeoforidou 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.

Reference Type BACKGROUND
PMID: 20947382 (View on PubMed)

Other Identifiers

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TEA and AF

Identifier Type: -

Identifier Source: org_study_id

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