Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

August 13, 2014 updated by: Virginia Commonwealth University

A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain control-visual analog pain score
Time Frame: post surgery monitoring
post surgery monitoring

Secondary Outcome Measures

Outcome Measure
Time Frame
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
Time Frame: post surgery monitoring
post surgery monitoring

Collaborators and Investigators

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

Sponsor

Virginia Commonwealth University

Collaborators

I-Flow

Investigators

  • Principal Investigator: Mark Nelson, MD, Virgina Commonwealth University, Dept of Anesthesia

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

September 1, 2006

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (ESTIMATE)

September 8, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VCU 011906

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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