We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Metaxia Bareka, Larissa University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718717
First Posted: October 31, 2012
Last Update Posted: July 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Metaxia Bareka, Larissa University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Thoracic Epidural Analgesia for Thoracic Surgery on Arrhythiogenesis

Resource links provided by NLM:


Further study details as provided by Metaxia Bareka, Larissa University Hospital:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 50
Study Start Date: December 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  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
First Submitted: October 28, 2012
First Posted: October 31, 2012
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