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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

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.

Condition or disease Intervention/treatment
Posterolateral Thoracotomy Lung Resection Thoracic Epidural Analgesia Sympathetic Outflow Atrial Fibrillation Other: Thoracic Epidural Analgesia (TEA) Other: TEA followed by Intravenous morphine

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis
Study Start Date : December 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017


Arm Intervention/treatment
Active Comparator: 6 days TEA
Postoperative analgesia for the first six postoperative days with TEA and daily monitoring for arrhythmia
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
Other: TEA followed by Intravenous morphine



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lung resection
  • pneumonectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718717


Contacts
Contact: Metaxia Bareka, Medicine 00306947845083 ext 1370 barekametaxia@hotmail.com
Contact: Marina Simaioforidou, Medicine 00306972202573 ext 1370 msimaiof@otenet.gr

Locations
Greece
Larissa University Hospital Not yet recruiting
Larissa, Thessally, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
Investigators
Principal Investigator: Metaxia Bareka, Medicine Larissa University Hospital
Study Chair: Marina Simaioforidou, Medicine Larissa University Hospital

Publications:

Responsible Party: Metaxia Bareka, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01718717     History of Changes
Other Study ID Numbers: TEA and AF
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by Metaxia Bareka, Larissa University Hospital:
Thoracotomy
Thoracic epidural analgesia
Arrythmiogenesis
Atrial fibrillation
Sympathetic outflow

Additional relevant MeSH terms:
Atrial Fibrillation
Agnosia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents