N/A
N=1,821
Multicenter Continuous Peripheral Nerve Block Surveillance Study
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00653133 ↗Enrolled (actual)
1,821
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Complications of Peripheral Nerve Block — 7; 14 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound imaging (Device); Peripheral nerve stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Halyard Health
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complications of Peripheral Nerve Block |
7; 14 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00653133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.