Multicenter Continuous Peripheral Nerve Block Surveillance Study

Halyard Health1,821 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,821

Conditions

Postoperative Pain

Interventions

Ultrasound imagingDEVICE

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

Peripheral nerve stimulatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Arizona Joint and Spine

Chandler, Arizona, United States

Santa Clara Valley Medical Center

San Jose, California, United States

Outcomes

Primary Outcomes

Complications of Peripheral Nerve Block

Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

Time frame: Preoperative through 3 days post operative

Data from ClinicalTrials.gov

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