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

This study is not yet open for participant recruitment.
Verified January 2013 by Larissa University Hospital
Sponsor:
Information provided by (Responsible Party):
Metaxia Bareka, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01718717
First received: October 28, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Occurrence of AF [ Time Frame: 6 postoperative days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 postoperative days ] [ Designated as safety issue: No ]
    The investigators will record the quality of analgesia, as it can be measured with VAS, for the 6 first postoperative days for all patients


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Metaxia Bareka, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01718717     History of Changes
Other Study ID Numbers: TEA and AF
Study First Received: October 28, 2012
Last Updated: January 7, 2013
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Morphine
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013