Clinical trial NCT00653133: Multicenter Continuous Peripheral Nerve Block Surveillance Study
Official title: Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: ultrasonography
peripheral nerve block
peripheral nerve stimulation
Lead sponsor: Halyard Health
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 1821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complications of Peripheral Nerve Block
timeFrame: Preoperative through 3 days post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Joint and Spine
state: Arizona
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Louisville
country: United States
facility: Avista Adventist Hospital
state: Colorado
city: Atlanta
country: United States
facility: Kennestone Hospital
state: Georgia
city: Bowling Green
country: United States
facility: The Medical Center of Bowling Green
state: Kentucky
city: Stoughton
country: United States
facility: Caritas Good Samaritan
state: Massachusetts
city: Hattiesburg
country: United States
facility: Wesley Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: DesPeres Hospital
state: Missouri
city: New York
country: United States
facility: St. Vincents Catholic Medical Center
state: New York
city: Charlotte
country: United States
facility: Charlotte Medical Center
state: North Carolina
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Owasso
country: United States
facility: Bailey Medical Center
state: Oklahoma
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Houston
country: United States
facility: Memorial Herman Hospital
state: Texas
city: Mount Pleasant
country: United States
facility: Titus Regional Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Roper Hospital, Charleston, SC
name: Joe Rodrigo, MD
role: PRINCIPAL_INVESTIGATOR
References: