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

July 9, 2014 updated by: Metaxia Bareka, Larissa University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marina Simaioforidou, Medicine
  • Phone Number: 1370 00306972202573
  • Email: msimaiof@otenet.gr

Study Locations

  • Greece
    • Thessally
      • Larissa, Thessally, Greece, 41110
        • Larissa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lung resection
  • pneumonectomy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Investigators

  • Principal Investigator: Metaxia Bareka, Medicine, Larissa University Hospital
  • Study Chair: Marina Simaioforidou, Medicine, Larissa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

October 28, 2012

First Submitted That Met QC Criteria

October 28, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEA and AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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