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Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653133
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : August 19, 2013
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Halyard Health

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Device: Ultrasound imaging Device: Peripheral nerve stimulator Not Applicable

Detailed Description:

Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.

This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1821 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: USPNB
Ultrasound imaging guided peripheral nerve block
 Device: Ultrasound imaging
Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
Active Comparator: NSPNB
Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic
 Device: Peripheral nerve stimulator
either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic


Outcome Measures
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Primary Outcome Measures :
  1. Complications of Peripheral Nerve Block [ Time Frame: Preoperative through 3 days post operative ]
    Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653133


Locations
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United States, Arizona
Arizona Joint and Spine
Chandler, Arizona, United States, 85224
United States, California
Santa Clara Valley Medical Center
San Jose, California, United States, 4088855230
United States, Colorado
Avista Adventist Hospital
Louisville, Colorado, United States, 80027
United States, Georgia
Kennestone Hospital
Atlanta, Georgia, United States, 30060
United States, Kentucky
The Medical Center of Bowling Green
Bowling Green, Kentucky, United States, 42101
United States, Massachusetts
Caritas Good Samaritan
Stoughton, Massachusetts, United States, 02072
United States, Mississippi
Wesley Medical Center
Hattiesburg, Mississippi, United States, 39402
United States, Missouri
DesPeres Hospital
Saint Louis, Missouri, United States, 63131
United States, New York
St. Vincents Catholic Medical Center
New York, New York, United States, 10011
United States, North Carolina
Charlotte Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45459
United States, Oklahoma
Bailey Medical Center
Owasso, Oklahoma, United States, 74055
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29403
United States, Texas
Memorial Herman Hospital
Houston, Texas, United States, 77030
Titus Regional Medical Center
Mount Pleasant, Texas, United States, 75455
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 25298
Sponsors and Collaborators
Halyard Health
Investigators
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Principal Investigator: Joe Rodrigo, MD Roper Hospital, Charleston, SC
More Information
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Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT00653133    
Other Study ID Numbers: iflocpnb2007
First Posted: April 4, 2008    Key Record Dates
Results First Posted: August 19, 2013
Last Update Posted: October 2, 2018
Last Verified: December 2014
Keywords provided by Halyard Health:
ultrasonography
peripheral nerve block
peripheral nerve stimulation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations