Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

Phase 1

Terminated

• Conditions: THoracotomy
• Interventions: Procedure: Extrapleural Intercostal Catheter; Procedure: Thoracic Epidural

• Registration Number: NCT00373633
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous extra-pleural intercostal local anesthesia	Extrapleural Intercostal Catheter	intra-operatively placed extrapleural intercostal catheter
Thoracic Epidural	Thoracic Epidural	gold standard

Primary Outcome Measures

Name	Time	Method
pain control-visual analog pain score	post surgery monitoring

Secondary Outcome Measures

Name	Time	Method
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities	post surgery monitoring

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States