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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:
Virginia Commonwealth University
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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 |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- pain control-visual analog pain score [ Time Frame: post surgery monitoring ]
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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00373633
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 |
Keywords provided by Virginia Commonwealth University:
|
THoracic Surgery thoracic epidural epidural thoracotomy |
intercostal nerve block intercostal nerve block |
ClinicalTrials.gov processed this record on July 19, 2017