Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
I-Flow
ClinicalTrials.gov Identifier:
NCT00653133
First received: March 28, 2008
Last updated: August 16, 2013
Last verified: August 2013
  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
Device: Peripheral nerve stimulator
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: Preoperative through 3 days post operative ] [ Designated as safety issue: Yes ]
    Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic


Enrollment: 1821
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: 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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
St. Louis, Missouri, United States, 63131
United States, New York
St. Vincents Catholic Medical Center
New York City, 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
I-Flow
Investigators
Principal Investigator: Joe Rodrigo, MD Roper Hospital, Charleston, SC
  More Information

Additional Information:
No publications provided

Responsible Party: I-Flow
ClinicalTrials.gov Identifier: NCT00653133     History of Changes
Other Study ID Numbers: iflocpnb2007
Study First Received: March 28, 2008
Results First Received: May 19, 2011
Last Updated: August 16, 2013
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014