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Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)

This study has been completed.
Sponsor:
Information provided by:
I-Flow
ClinicalTrials.gov Identifier:
NCT00653133
First received: March 28, 2008
Last updated: September 27, 2009
Last verified: September 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ultrasound guided nerve block
 Device: Ultrasound imaging plus ON-Q Cbloc
Ultrasound guided techniques
Active Comparator: 2
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

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

No publications provided

Responsible Party: Barbara Saint John/Director, I-Flow Corporation
ClinicalTrials.gov Identifier: NCT00653133     History of Changes
Other Study ID Numbers: iflocpnb2007
Study First Received: March 28, 2008
Last Updated: September 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by I-Flow:
ultrasonography
peripheral nerve block
peripheral nerve stimulation

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013