Multicenter Continuous Peripheral Nerve Block Surveillance Study

Postoperative Pain Clinical Trial

— cpnb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653133
• Other study ID #: iflocpnb2007
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: March 2009

Study information

• Verified date: December 2014
• Source: Halyard Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1821
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Ultrasound imaging
Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
• Peripheral nerve stimulator
either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic

Locations

Country	Name	City	State
United States	Kennestone Hospital	Atlanta	Georgia
United States	The Medical Center of Bowling Green	Bowling Green	Kentucky
United States	Arizona Joint and Spine	Chandler	Arizona
United States	Roper Hospital	Charleston	South Carolina
United States	Charlotte Medical Center	Charlotte	North Carolina
United States	Miami Valley Hospital	Dayton	Ohio
United States	Wesley Medical Center	Hattiesburg	Mississippi
United States	Memorial Herman Hospital	Houston	Texas
United States	Avista Adventist Hospital	Louisville	Colorado
United States	Titus Regional Medical Center	Mount Pleasant	Texas
United States	St. Vincents Catholic Medical Center	New York	New York
United States	Bailey Medical Center	Owasso	Oklahoma
United States	Virginia Commonwealth University	Richmond	Virginia
United States	DesPeres Hospital	Saint Louis	Missouri
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Caritas Good Samaritan	Stoughton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Halyard Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications of Peripheral Nerve Block	Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic	Preoperative through 3 days post operative