Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

This study has been terminated.

(terminated due to diminishing frequency of thorocotomies and slow enrollment)

Sponsor:

Collaborator:

I-Flow

Information provided by (Responsible Party):

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT00373633

First received: September 6, 2006

Last updated: August 13, 2014

Last verified: August 2014

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: Thoracic Epidural Procedure: Extrapleural Intercostal Catheter	Phase 1


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

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

pain control-visual analog pain score [ Time Frame: post surgery monitoring ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities [ Time Frame: post surgery monitoring ] [ Designated as safety issue: Yes ]


Enrollment:	26
Study Start Date:	September 2006
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00373633 History of Changes
Other Study ID Numbers:	VCU 011906
Study First Received:	September 6, 2006
Last Updated:	August 13, 2014
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

Additional relevant MeSH terms:


Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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