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

Atrial Fibrillation Clinical Trial

Official title:

Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01718717
• Other study ID #: TEA and AF
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2012
• Last updated: July 9, 2014
• Start date: December 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2014
• Source: Larissa University Hospital
• Contact: Metaxia Bareka, Medicine
• Phone: 00306947845083
• Email: barekametaxia[@]hotmail.com
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• lung resection

• pneumonectomy

Exclusion Criteria:

• Patient refusal

• AF (present or in the past

• contraindications for epidural catheter placement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Thoracic Epidural Analgesia (TEA)

• TEA followed by Intravenous morphine

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thessally

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (9)

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. Review. — View 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. — View Citation

O'Higgins F, Tuckey JP. Thoracic epidural anaesthesia and analgesia: United Kingdom practice. Acta Anaesthesiol Scand. 2000 Oct;44(9):1087-92. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 postoperative days	No
Secondary	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	6 postoperative days	No