Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain
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ClinicalTrials.gov Identifier: NCT00373633 |
Recruitment Status
:
Terminated
(terminated due to diminishing frequency of thorocotomies and slow enrollment)
First Posted
: September 8, 2006
Last Update Posted
: August 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
THoracotomy | Procedure: Thoracic Epidural Procedure: Extrapleural Intercostal Catheter | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

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
|
- pain control-visual analog pain score [ Time Frame: post surgery monitoring ]
- respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities [ Time Frame: post surgery monitoring ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373633
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Mark Nelson, MD | Virgina Commonwealth University, Dept of Anesthesia |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00373633 History of Changes |
Other Study ID Numbers: |
VCU 011906 |
First Posted: | September 8, 2006 Key Record Dates |
Last Update Posted: | August 15, 2014 |
Last Verified: | August 2014 |
Keywords provided by Virginia Commonwealth University:
THoracic Surgery thoracic epidural epidural thoracotomy |
intercostal nerve block intercostal nerve block |