Improvement of Needle Visibility in Ultrasound Guided Regional Anaesthesia
NCT ID: NCT01583010
Last Updated: 2012-04-23
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-12-31
2012-05-31
Brief Summary
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Our study pursues another approach. We use (for differentiation) echogenic nerve block needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization Technology®). We will compare UGRA with ANV® against standard UGRA without using this SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks as part of their routine anesthetic management are included.
This work represents the first randomized controlled double blinded clinical trial of ANV® in patients undergoing UGRA. We hypothesize, that we can decrease the time without needle visualization (Loss of needle time in percentage of procedure time) during in-line regional anaesthesia. Furthermore we will record quality of visibility, duration of procedure and insertion angle of the needle.
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Detailed Description
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An experienced anaesthesiologist from department of anaesthesiology, general intensive care and pain medicine will perform UGRA. Because of safety reasons and best assessment of needle visibility all UGRA in this study are going to performed with in-plane ultrasound technique. Needle length and gauge are standardized.
The ultrasound imaging of each nerve block gets recorded onto a DVD for analysis. Recording of performed UGRA will start with placement of ultrasound probe and will finish with needle leaving the skin (procedure time), get stored, checked to exclude technical failures and analysed with a one second discrimination by two blinded observers for needle visibility. All information indicating ANV®-status on ultrasound image will be deleted. Hence for procedure and following analysis we will ensure that patient and the objective observer are blinded.
Images with full needle visibility will be related to images without needle visibility. Time of needle visibility will be described in percent of procedure time.
Enduring visualization of complete needle in ultrasound beam won't be given during the whole procedure. For differentiation of complete needle visibility, partial or no visibility in in-plane UGRA, we will use needles with ultrasound visible marks (echogenic needles). If the objective observers will visualize all 3 marks and pole of the needle in ultrasound-image, needle is completely in-plane and visible for analysis. For partial visibility of marks we will use a needle visibility grading dependent to number of visible marks (One mark = poor visibility, two marks = middle visibility, three marks=good visibility). If there won't be visible marks in ultrasound image, needle is in absence and gets evaluated as "not visible".
Dependent to position of anatomic target structure each nerve block will need a different angle of needle insertion. This measured angle will be used to compare times of needle visibility dependent to insertion angle of the needle. Significant differences may appear especially in steep angles of needle.
In this study we will use Naropin® (Ropivaciane, 7.5mg/ml) as local anaesthetic for all UGRA.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Standard Treatment Group
Patients receiving ultrasound guided regional anaesthesia without using Advanced Needle Visualization Technology(R)
No interventions assigned to this group
ANV ® Group
Patients receiving ultrasound guided regional anaesthesia with using Advanced Needle Visualization Technology(R)
ANV(R)
Device: Advanced Needle Visualization Technology ®
Software update for SonoSites M-Turbo® and S-series™ ultrasound systems with enhanced 15-20Mhz ultrasound probe.
Arms: ANV ® Group
Interventions
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ANV(R)
Device: Advanced Needle Visualization Technology ®
Software update for SonoSites M-Turbo® and S-series™ ultrasound systems with enhanced 15-20Mhz ultrasound probe.
Arms: ANV ® Group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Reinhard Hahn
Dr.
Principal Investigators
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Reinhard Hahn, Univ. Lektor Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Medical University Vienna
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Hebard S, Hocking G. Echogenic technology can improve needle visibility during ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):185-9. doi: 10.1097/aap.0b013e31820d4349.
Maecken T, Zenz M, Grau T. Ultrasound characteristics of needles for regional anesthesia. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):440-7. doi: 10.1016/j.rapm.2007.07.002.
Chapman GA, Johnson D, Bodenham AR. Visualisation of needle position using ultrasonography. Anaesthesia. 2006 Feb;61(2):148-58. doi: 10.1111/j.1365-2044.2005.04475.x.
Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. doi: 10.1016/j.rapm.2008.06.002.
Other Identifiers
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EK572/2011
Identifier Type: -
Identifier Source: org_study_id
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