Prospective Post-market Evaluation of an Echogenic Catheter
NCT ID: NCT02136446
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-09-30
2015-10-31
Brief Summary
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Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.
The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EchoGlo™ Peripheral Nerve Block Catheter
Echogenic nerve block catheter (test)
EchoGlo Nerve Block Catheter
Catheter used for a paravertebral anesthesia block
Pajunk® EpiLong Catheter
Non-echogenic nerve block catheter (control)
Pajunk® Nerve Block Catheter
Nerve Block Catheter
Interventions
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EchoGlo Nerve Block Catheter
Catheter used for a paravertebral anesthesia block
Pajunk® Nerve Block Catheter
Nerve Block Catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
* Patients at least 18 years old
* Patient is willing and able to provide informed consent for study participation
* Patient has a good understanding of written and verbal English
Exclusion Criteria
* Patient with known coagulopathy
* Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
* Patients having mastectomy and immediate reconstruction
18 Years
ALL
No
Sponsors
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Smiths Medical, ASD, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter R Kratz, MS
Role: STUDY_DIRECTOR
Smiths Medical
Locations
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University College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EchoCath
Identifier Type: -
Identifier Source: org_study_id
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