Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

THoracotomy Clinical Trial

Official title:

A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00373633
• Other study ID #: VCU 011906
• Status: Terminated
• Phase: Phase 1
• First received: September 6, 2006
• Last updated: August 13, 2014
• Start date: September 2006
• Est. completion date: January 2012

Study information

• Verified date: August 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• THoracotomy

Intervention

Procedure:
• Thoracic Epidural
Gold standard for post thoracotomy pain
• Extrapleural Intercostal Catheter
Continuous extra-pleural intercostal local anesthesia

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	I-Flow

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain control-visual analog pain score		post surgery monitoring	No
Secondary	respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities		post surgery monitoring	Yes