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Extrapleural Intercostal Catheter Vs. Thoracic Epidural for Thoracotomy Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
I-Flow
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00373633
First received: September 6, 2006
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

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 Intervention Phase
Thoracotomy
 Procedure: extrapleural intercostal catheter vs. thoracic epidural
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • pain control-visual analog pain score

Secondary Outcome Measures:
  • respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373633

Contacts
Contact: Mark Nelson, MD 804-373-7987 Mnelson3@vcu.edu
Contact: Darrin Letsinger, MD 804-828-4999 ext 1646 dletsinger@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Mark Nelson, MD     804-373-7987     Mnelson3@vcu.edu    
Contact: Jay Napoleon, MD     804-828-0733        
Sub-Investigator: Darrin B Letsinger, MD, MS            
Sub-Investigator: Danielle Lindenmuth, MD            
Sponsors and Collaborators
Virginia Commonwealth University
I-Flow
Investigators
Principal Investigator: Mark Nelson, MD Virgina Commonwealth University, Dept of Anesthesia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00373633     History of Changes
Other Study ID Numbers: VCU 011906
Study First Received: September 6, 2006
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013