Multicenter Continuous Peripheral Nerve Block Surveillance Study

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: Ultrasound imaging; Device: Peripheral nerve stimulator

• Registration Number: NCT00653133
• Lead Sponsor: Halyard Health

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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2011-05-19
• Results First Submitted QC: 2013-08-16
• Results First Posted: 2013-08-19
• Status Verified: 2014-12
• Last Update Submitted: 2018-09-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1821

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USPNB	Ultrasound imaging	Ultrasound imaging guided peripheral nerve block
NSPNB	Peripheral nerve stimulator	Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic

Primary Outcome Measures

Name	Time	Method
Complications of Peripheral Nerve Block	Preoperative through 3 days post operative	Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

Trial Locations

Locations (16)

Avista Adventist Hospital; 🇺🇸 Louisville, Colorado, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

Kennestone Hospital; 🇺🇸 Atlanta, Georgia, United States

The Medical Center of Bowling Green; 🇺🇸 Bowling Green, Kentucky, United States

Caritas Good Samaritan; 🇺🇸 Stoughton, Massachusetts, United States

DesPeres Hospital; 🇺🇸 Saint Louis, Missouri, United States

St. Vincents Catholic Medical Center; 🇺🇸 New York, New York, United States

Miami Valley Hospital; 🇺🇸 Dayton, Ohio, United States

Charlotte Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Bailey Medical Center; 🇺🇸 Owasso, Oklahoma, United States

Memorial Herman Hospital; 🇺🇸 Houston, Texas, United States

Roper Hospital; 🇺🇸 Charleston, South Carolina, United States

Titus Regional Medical Center; 🇺🇸 Mount Pleasant, Texas, United States

Arizona Joint and Spine; 🇺🇸 Chandler, Arizona, United States

Wesley Medical Center; 🇺🇸 Hattiesburg, Mississippi, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States