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Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

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ClinicalTrials.gov Identifier: NCT00373633
Recruitment Status : Terminated (terminated due to diminishing frequency of thorocotomies and slow enrollment)
First Posted : September 8, 2006
Last Update Posted : August 15, 2014
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.

Condition or disease Intervention/treatment Phase
THoracotomy Procedure: Thoracic Epidural Procedure: Extrapleural Intercostal Catheter Phase 1

Detailed Description:
The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups[Figure 1]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
Study Start Date : September 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Continuous extra-pleural intercostal local anesthesia
intra-operatively placed extrapleural intercostal catheter
 Procedure: Extrapleural Intercostal Catheter
Continuous extra-pleural intercostal local anesthesia
Active Comparator: Thoracic Epidural
gold standard
 Procedure: Thoracic Epidural
Gold standard for post thoracotomy pain


Outcome Measures
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Primary Outcome Measures :
  1. pain control-visual analog pain score [ Time Frame: post surgery monitoring ]

Secondary Outcome Measures :
  1. respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities [ Time Frame: post surgery monitoring ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral thoracotomy
  • Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy

Exclusion Criteria:

  • Bilateral thoracotomy
  • Planned bilateral thoracotomy
  • Planned chest wall resection
  • Planned combined thoracotomy and laparotomy procedure
  • VATS procedure without conversion to unilateral thoracotomy
  • Emergency operation
  • Critically ill patients
  • Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility
  • Patients who are unable to give informed consent
  • Patients with preoperative chronic back or chest wall pain
  • Empyema or other infective condition increasing the risk of epidural infection
  • Coagulopathy
  • Decision of the surgeon or anesthesiologist, or choice of the patient
  • Infection at site of epidural placement
  • Patients with other co morbidities which exclude thoracic epidural placement
  • Patients under the age of 18 years
Contacts and Locations
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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): NCT00373633


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
I-Flow
Investigators
Principal Investigator: Mark Nelson, MD Virgina Commonwealth University, Dept of Anesthesia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00373633     History of Changes
Other Study ID Numbers: VCU 011906
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by Virginia Commonwealth University:
THoracic Surgery
thoracic epidural
epidural
thoracotomy
 intercostal nerve block
intercostal
nerve block