Clinical trial NCT00373633: Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain
Official title: A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: THoracotomy
Keywords: THoracic Surgery
thoracic epidural
epidural
thoracotomy
intercostal nerve block
intercostal
nerve block
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: I-Flow
First posted: 2006-09-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: pain control-visual analog pain score
timeFrame: post surgery monitoring
Secondary outcomes:
measure: respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
timeFrame: post surgery monitoring
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virgina Commonwealth University, Dept of Anesthesia
name: Mark Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: