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Status unknownNCT01718717Updated Jul 10, 2014

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

An interventional study of Thoracic Epidural Analgesia (TEA) and TEA followed by Intravenous morphine in Posterolateral Thoracotomy, Lung Resection and Thoracic Epidural Analgesia, sponsored by Larissa University Hospital. Status unknown at 1 site in Greece. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-07-10.

Sponsored by Larissa University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Posterolateral Thoracotomy
  • Lung Resection
  • Thoracic Epidural Analgesia
  • Sympathetic Outflow
  • Atrial Fibrillation

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Keywords

  • Thoracotomy
  • Thoracic epidural analgesia
  • Arrythmiogenesis
  • Atrial fibrillation
  • Sympathetic outflow
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 50 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Larissa University Hospital is the lead sponsor of 41 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • lung resection
  • pneumonectomy

Exclusion criteria

Exclusion Criteria:

  • Patient refusal
  • AF (present or in the past
  • contraindications for epidural catheter placement
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    6 days TEA

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

    Other: Thoracic Epidural Analgesia (TEA)

  • Active comparator
    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

    Other: TEA followed by Intravenous morphine

Interventions

  • OtherThoracic Epidural Analgesia (TEA)
  • OtherTEA followed by Intravenous morphine
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 6 postoperative days

07

Study locations

1 site
  • Larissa University Hospital
    Larissa, Thessally 41110, Greece
08

References and documents

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 11118174 ↗
  • 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. PubMed 11028728 ↗
  • 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. PubMed 19189982 ↗
  • 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. PubMed 18953284 ↗
  • 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. PubMed 19307137 ↗
  • 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. PubMed 19854794 ↗
  • 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. PubMed 17670334 ↗
  • 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. PubMed 11473839 ↗
  • 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. PubMed 20947382 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01718717
Lead sponsor
Larissa University Hospital
Responsible party
Metaxia Bareka (Anesthesiologist, Larissa University Hospital) — Principal investigator
First posted
Oct 31, 2012
Start date
Dec 2014
Primary completion
Jan 2016 (estimated)
Completion
Jan 2017 (estimated)
Last update
Jul 10, 2014

Study contacts

Metaxia Bareka, Medicine
Contact
barekametaxia@hotmail.com
00306947845083 ext. 1370
Marina Simaioforidou, Medicine
Contact
msimaiof@otenet.gr
00306972202573 ext. 1370
Metaxia Bareka, Medicine
principal investigator · Larissa University Hospital
Marina Simaioforidou, Medicine
study chair · Larissa University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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