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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
  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
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

No publications provided

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 Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014