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NCT Number: NCT00653133

Multicenter Continuous Peripheral Nerve Block Surveillance Study

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Joint and Spine, Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Imaging

Device

Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic

Peripheral Nerve Stimulator

Device

either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Halyard Health

Industry

Registry information

Official study title

Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques

Acronym: cpnb

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 4, 2008
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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