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

Primary Purpose

Posterolateral Thoracotomy, Lung Resection, Thoracic Epidural Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Thoracic Epidural Analgesia (TEA)
TEA followed by Intravenous morphine
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posterolateral Thoracotomy focused on measuring Thoracotomy, Thoracic epidural analgesia, Arrythmiogenesis, Atrial fibrillation, Sympathetic outflow

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lung resection
  • pneumonectomy

Exclusion Criteria:

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

Sites / Locations

  • Larissa University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

6 days TEA

3 days TEA and 3 days intravenous morphine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2012
Last Updated
July 9, 2014
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01718717
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterolateral Thoracotomy, Lung Resection, Thoracic Epidural Analgesia, Sympathetic Outflow, Atrial Fibrillation
Keywords
Thoracotomy, Thoracic epidural analgesia, Arrythmiogenesis, Atrial fibrillation, Sympathetic outflow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 days TEA
Arm Type
Active Comparator
Arm Description
Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia
Arm Title
3 days TEA and 3 days intravenous morphine
Arm Type
Active Comparator
Arm Description
Postoperative analgesia for the first three postoperative days with TEA followed for the next three days with intravenous morphine, and daily monitoring for arrhythmia
Intervention Type
Other
Intervention Name(s)
Thoracic Epidural Analgesia (TEA)
Intervention Type
Other
Intervention Name(s)
TEA followed by Intravenous morphine
Primary Outcome Measure Information:
Title
Occurrence of AF
Description
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 Outcome Measure Information:
Title
Quality of analgesia
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lung resection pneumonectomy Exclusion Criteria: Patient refusal AF (present or in the past contraindications for epidural catheter placement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Metaxia Bareka, Medicine
Phone
00306947845083
Ext
1370
Email
barekametaxia@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Simaioforidou, Medicine
Phone
00306972202573
Ext
1370
Email
msimaiof@otenet.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metaxia Bareka, Medicine
Organizational Affiliation
Larissa University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Simaioforidou, Medicine
Organizational Affiliation
Larissa University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Larissa University Hospital
City
Larissa
State/Province
Thessally
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
11118174
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.
Results Reference
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PubMed Identifier
11028728
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.
Results Reference
background
PubMed Identifier
19189982
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.
Results Reference
background
PubMed Identifier
18953284
Citation
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.
Results Reference
background
PubMed Identifier
19307137
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.
Results Reference
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PubMed Identifier
19854794
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.
Results Reference
background
PubMed Identifier
17670334
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.
Results Reference
background
PubMed Identifier
11473839
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.
Results Reference
background
PubMed Identifier
20947382
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.
Results Reference
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Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF

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