Multicenter Continuous Peripheral Nerve Block Surveillance Study - Full Text View

Sponsored by:	I-Flow
Information provided by:	I-Flow
ClinicalTrials.gov Identifier:	NCT00653133

Purpose

This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.

Condition	Intervention	Phase
Postoperative Pain	Device: Ultrasound imaging plus ON-Q Cbloc Device: Peripheral nerve stimulator plus ON-Q Cbloc	Phase IV

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques

Further study details as provided by I-Flow:

Primary Outcome Measures:

complications of peripheral nerve block [ Time Frame: acute treatment phase ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3400
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ultrasound guided nerve block	Device: Ultrasound imaging plus ON-Q Cbloc Ultrasound guided techniques
2: Active Comparator Stimulator guided nerve block	Device: Peripheral nerve stimulator plus ON-Q Cbloc either stimulating needle or stimulating catheter

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
Age >18
Able to give consent

Exclusion Criteria:

Morbid obesity (BMI> 40)
Uncooperative or having psychological or linguistic difficulties
Previous damage to the nerve or plexus
Significant comorbidities which the primary investigator feels would limit the quality and collection of data
Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653133

Locations

United States, Arizona
Arizona Joint and Spine
Chandler, Arizona, United States, 85224
United States, Colorado
Avista Adventist Hospital
Louisville, Colorado, United States, 80027
United States, Texas
Memorial Herman Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

I-Flow

More Information

Click here for more information on nerve block This link exits the ClinicalTrials.gov site

Responsible Party:	I-Flow Corporation ( Barbara Saint John/Director )
Study ID Numbers:	iflocpnb2007
Study First Received:	March 28, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00653133
Health Authority:	United States: Institutional Review Board

Keywords provided by I-Flow:

ultrasonography
peripheral nerve block
peripheral nerve stimulation

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009