Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 10, 2014
July 1, 2014
1.1 years
October 28, 2012
July 9, 2014
Conditions
Keywords
Outcome Measures
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
6 postoperative days
Secondary Outcomes (1)
Quality of analgesia
6 postoperative days
Study Arms (2)
6 days TEA
ACTIVE COMPARATORPostoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia
3 days TEA and 3 days intravenous morphine
ACTIVE COMPARATORPostoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia
Interventions
Eligibility Criteria
You may qualify if:
- lung resection
- pneumonectomy
You may not qualify if:
- Patient refusal
- AF (present or in the past
- contraindications for epidural catheter placement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Larissa University Hospital
Larissa, Thessally, 41110, Greece
Related Publications (9)
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.
PMID: 11118174BACKGROUNDO'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.
PMID: 11028728BACKGROUNDMendola 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.
PMID: 19189982BACKGROUNDDe 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.
PMID: 18953284BACKGROUNDWildgaard 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.
PMID: 19307137BACKGROUNDScarci 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.
PMID: 19854794BACKGROUNDShrivastava 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.
PMID: 17670334BACKGROUNDOka 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.
PMID: 11473839BACKGROUNDSimeoforidou 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.
PMID: 20947382BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Metaxia Bareka, Medicine
Larissa University Hospital
- STUDY CHAIR
Marina Simaioforidou, Medicine
Larissa University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
October 28, 2012
First Posted
October 31, 2012
Study Start
December 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2017
Last Updated
July 10, 2014
Record last verified: 2014-07