Extrapleural Intercostal Catheter vs. Thoracic Epidural f... | NCT00373633

Studies
Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

NCT00373633

Sponsor

Virginia Commonwealth University

Status

Terminated

Last Update Posted

Aug 15, 2014Estimated

Enrollment

26Actual

Phase

Phase 1

Conditions

THoracotomy

Interventions

Thoracic Epidural
Extrapleural Intercostal Catheter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated due to diminishing frequency of thorocotomies and slow enrollment

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 6, 2006

First Submission Date that Met QC Criteria

Sep 7, 2006

First Posted Date

Sep 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Name	Class
I-Flow	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous extra-pleural intercostal local anesthesia	Experimental	intra-operatively placed extrapleural intercostal catheter	Procedure: Extrapleural Intercostal Catheter
Thoracic Epidural	Active Comparator	gold standard	Procedure: Thoracic Epidural

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracic Epidural	Procedure	Gold standard for post thoracotomy pain	Thoracic Epidural

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain control-visual analog pain score		post surgery monitoring

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Nelson, MD	Virgina Commonwealth University, Dept of Anesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

Intervention Browse Module

MeSH Terms

ID	Term
D013662	Tea

Ancestor Terms

ID	Term
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures
D001628	Beverages

Browse Leaves

Not provided

Browse Branches

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