Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)

September 1, 2018 updated by: Halyard Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1821

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Joint and Spine
    • California
      • San Jose, California, United States, 4088855230
        • Santa Clara Valley Medical Center
    • Colorado
      • Louisville, Colorado, United States, 80027
        • Avista Adventist Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30060
        • Kennestone Hospital
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • The Medical Center of Bowling Green
    • Massachusetts
      • Stoughton, Massachusetts, United States, 02072
        • Caritas Good Samaritan
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39402
        • Wesley Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • DesPeres Hospital
    • New York
      • New York, New York, United States, 10011
        • St. Vincents Catholic Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Charlotte Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Miami Valley Hospital
    • Oklahoma
      • Owasso, Oklahoma, United States, 74055
        • Bailey Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Roper Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Herman Hospital
      • Mount Pleasant, Texas, United States, 75455
        • Titus Regional Medical Center
    • Virginia
      • Richmond, Virginia, United States, 25298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative through 3 days post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halyard Health

Investigators

  • Principal Investigator: Joe Rodrigo, MD, Roper Hospital, Charleston, SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 1, 2018

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iflocpnb2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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