Trauma Clinical Trial
Official title:
Improvement of Needle Visibility in In-line Regional Anaesthesia by "Advanced Needle Visualization Technology ®"
Needle tip visualization, although fundamental to the safety and efficacy of
ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is
most marked at steep insertion angles. Studies in patients with UGRA demonstrate that
echogenic needle designs have the potential to offer improved visibility and accuracy.
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.
Patients scheduled to undergo surgery with femoral (n = 50) and supraclavicular (n=50)
anaesthesia (100 blocks total) gets included in this study. These 50 patients will be
randomized equally using sealed opaque envelopes to two parallel groups: standard treatment
UGRA (n=25) and SonoSites ANV® (n= 25) UGRA.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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