Multicenter Continuous Peripheral Nerve Block Surveillance Study

NCT ID: NCT00653133

Last Updated: 2018-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1821 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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USPNB

Ultrasound imaging guided peripheral nerve block

Group Type ACTIVE_COMPARATOR

Ultrasound imaging

Intervention Type DEVICE

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

NSPNB

Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic

Group Type ACTIVE_COMPARATOR

Peripheral nerve stimulator

Intervention Type DEVICE

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

Interventions

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Ultrasound imaging

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

Intervention Type DEVICE

Peripheral nerve stimulator

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halyard Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joe Rodrigo, MD

Role: PRINCIPAL_INVESTIGATOR

Roper Hospital, Charleston, SC

Locations

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Arizona Joint and Spine

Chandler, Arizona, United States

Site Status

Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Avista Adventist Hospital

Louisville, Colorado, United States

Site Status

Kennestone Hospital

Atlanta, Georgia, United States

Site Status

The Medical Center of Bowling Green

Bowling Green, Kentucky, United States

Site Status

Caritas Good Samaritan

Stoughton, Massachusetts, United States

Site Status

Wesley Medical Center

Hattiesburg, Mississippi, United States

Site Status

DesPeres Hospital

St Louis, Missouri, United States

Site Status

St. Vincents Catholic Medical Center

New York, New York, United States

Site Status

Charlotte Medical Center

Charlotte, North Carolina, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Bailey Medical Center

Owasso, Oklahoma, United States

Site Status

Roper Hospital

Charleston, South Carolina, United States

Site Status

Memorial Herman Hospital

Houston, Texas, United States

Site Status

Titus Regional Medical Center

Mount Pleasant, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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iflocpnb2007

Identifier Type: -

Identifier Source: org_study_id

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