Clinical trial NCT01718717: Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF
Official title: Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterolateral Thoracotomy
Lung Resection
Thoracic Epidural Analgesia
Sympathetic Outflow
Atrial Fibrillation
Keywords: Thoracotomy
Thoracic epidural analgesia
Arrythmiogenesis
Atrial fibrillation
Sympathetic outflow
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* lung resection
* pneumonectomy

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of AF
timeFrame: 6 postoperative days
Secondary outcomes:
measure: Quality of analgesia
timeFrame: 6 postoperative days
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessally
Study officials:
affiliation: Larissa University Hospital
name: Metaxia Bareka, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Larissa University Hospital
name: Marina Simaioforidou, Medicine
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.