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

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ClinicalTrials.gov Identifier: NCT01718717
Recruitment Status : Unknown
Verified July 2014 by Metaxia Bareka, Larissa University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2012
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Metaxia Bareka, Larissa University Hospital

October 28, 2012
October 31, 2012
July 10, 2014
December 2014
January 2016   (Final data collection date for primary outcome measure)
Occurrence of AF [ Time Frame: 6 postoperative days ]
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
Same as current
Complete list of historical versions of study NCT01718717 on ClinicalTrials.gov Archive Site
Quality of analgesia [ Time Frame: 6 postoperative days ]
The investigators will record the quality of analgesia, as it can be measured with VAS, for the 6 first postoperative days for all patients
Same as current
Not Provided
Not Provided
 
Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF
Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis
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.

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

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Posterolateral Thoracotomy
  • Lung Resection
  • Thoracic Epidural Analgesia
  • Sympathetic Outflow
  • Atrial Fibrillation
  • Other: Thoracic Epidural Analgesia (TEA)
  • Other: TEA followed by Intravenous morphine
  • Active Comparator: 6 days TEA
    Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia
    Intervention: 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
    Intervention: Other: TEA followed by Intravenous morphine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
January 2017
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • lung resection
  • pneumonectomy

Exclusion Criteria:

  • Patient refusal
  • AF (present or in the past
  • contraindications for epidural catheter placement
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01718717
TEA and AF
No
Not Provided
Not Provided
Metaxia Bareka, Larissa University Hospital
Larissa University Hospital
Not Provided
Principal Investigator: Metaxia Bareka, Medicine Larissa University Hospital
Study Chair: Marina Simaioforidou, Medicine Larissa University Hospital
Larissa University Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP