Multicenter Continuous Peripheral Nerve Block Surveillance Study

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Ultrasound imaging
* Device: Peripheral nerve stimulator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: USPNB<br>Ultrasound imaging guided peripheral nerve block | Device: Ultrasound imaging<br>* Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic<br>|
| Active Comparator: NSPNB<br>Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic | Device: Peripheral nerve stimulator<br>* either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasonography, peripheral nerve block, peripheral nerve stimulation