Study Stopped
terminated due to diminishing frequency of thorocotomies and slow enrollment
Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain
A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 6, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedAugust 15, 2014
August 1, 2014
5.3 years
September 6, 2006
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain control-visual analog pain score
post surgery monitoring
Secondary Outcomes (1)
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
post surgery monitoring
Study Arms (2)
Continuous extra-pleural intercostal local anesthesia
EXPERIMENTALintra-operatively placed extrapleural intercostal catheter
Thoracic Epidural
ACTIVE COMPARATORgold standard
Interventions
Continuous extra-pleural intercostal local anesthesia
Eligibility Criteria
You may qualify if:
- Unilateral thoracotomy
- Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- I-Flowcollaborator
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Nelson, MD
Virgina Commonwealth University, Dept of Anesthesia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2006
First Posted
September 8, 2006
Study Start
September 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
August 15, 2014
Record last verified: 2014-08