Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Halyard Health
- Enrollment
- 1,821
- Locations
- 31
- Primary Endpoint
- Complications of Peripheral Nerve Block
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
- •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
Outcomes
Primary Outcomes
Complications of Peripheral Nerve Block
Time Frame: Preoperative through 3 days post operative
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Secondary Outcomes
No secondary outcomes reported