Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

NCT ID: NCT00373633

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-01-31

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.

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.

Conditions

THoracotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Continuous extra-pleural intercostal local anesthesia

intra-operatively placed extrapleural intercostal catheter

Group Type: EXPERIMENTAL

Extrapleural Intercostal Catheter

Intervention Type: PROCEDURE

Continuous extra-pleural intercostal local anesthesia

Thoracic Epidural

gold standard

Group Type: ACTIVE_COMPARATOR

Thoracic Epidural

Intervention Type: PROCEDURE

Gold standard for post thoracotomy pain

Interventions

Thoracic Epidural

Gold standard for post thoracotomy pain

Intervention Type: PROCEDURE

Extrapleural Intercostal Catheter

Continuous extra-pleural intercostal local anesthesia

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I-Flow

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Virgina Commonwealth University, Dept of Anesthesia

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VCU 011906

Identifier Type: -

Identifier Source: org_study_id