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      Non-inferiority trial of a pedal controlled injection device: a step toward enhancing patient safety and operator independence during neural blockade

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          Background and objectives

          Limitations in manpower in health care facilities, both in civilian and military settings, can severely affect patient safety as well as overall outcomes. Regional anesthesia via neural blockade is an effective means of managing uncontrolled acute pain, which has been associated with cardiopulmonary, endocrine, immunologic, and hematologic derangement in addition to the development of potentially life-threatening coagulopathy. We have designed a remote-controlled injection device that may expedite the performance of regional nerve blocks in these situations.


          This work examines how the device affects the ability of the operator to act independently with respect to various block component times by statistically comparing device-assisted blockade with usual or clinically relevant techniques. The classic or two-person technique was compared with the foot-controlled technique.


          The results validated the hypothesis that the novel mechanism of performing a nerve block is not inferior to the classic technique with regard to the specified endpoints within our experimental design.


          This confirmation indicates that the use of this device may be feasible when the use of another technique could be cumbersome, or otherwise untenable.

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          Most cited references 4

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          The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary.

          The American Society of Regional Anesthesia and Pain Medicine charged an expert panel to examine the evidence basis for ultrasound guidance as a nerve localization tool in the clinical practices of regional anesthesia and interventional pain medicine. The panel searched, examined, and assessed the literature of ultrasound-guided regional anesthesia (UGRA) from the past 20 years. The qualities of studies were graded using the Jadad score. Strength of evidence and recommendations were graded using an accepted rating tool. The panel made specific literature-based assessments concerning the relative advantages and limitations of UGRA relative to traditional nerve localization methods as they pertained to block characteristics and complications. Assessments and recommendations were made for upper and lower extremity, neuraxial, and truncal blocks and include pediatrics and interventional pain medicine. Ultrasound guidance improves block characteristics (particularly performance time and surrogate measures of success) that are often block specific and that may impart an efficiency advantage depending on individual practitioner circumstances. Evidence for UGRA impacting patient safety is currently limited to the demonstration of improvements in the frequency of surrogate events for serious complications.
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            Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia.

            Ultrasound-guided regional anesthesia is a rapidly growing field. There exists little information regarding the competencies involved with such a practice. The objective of this exploratory study was to characterize the behavior of novices as they undertook the challenges of learning a new technique. In addition to assessing for both committed errors and accuracy, we aimed to identify previously unrecognized quality-compromising behaviors that could help structure effective training interventions. By using detailed video analyses, the performances of 6 anesthesia residents were evaluated while on a dedicated 1-month rotation in ultrasound-guided regional anesthesia. From these video reviews, we assessed accuracy, errors committed, performance times, and searched for previously unrecognized quality-compromising behaviors. A total of 520 nerve blocks were videotaped and reviewed. All residents performed at least 66 nerve blocks, with an overall success rate of 93.6% and 4 complications. Both speed and accuracy improved throughout the rotation. There were a total of 398 errors committed, with the 2 most common errors consisting of the failure to visualize the needle before advancement and unintentional probe movement. Five quality-compromising patterns of behavior were identified: (1) failure to recognize the maldistribution of local anesthesia, (2) failure to recognize an intramuscular location of the needle tip before injection, (3) fatigue, (4) failure to correctly correlate the sidedness of the patient with the sidedness of the ultrasound image, and (5) poor choice of needle-insertion site and angle with respect to the probe preventing accurate needle visualization. Based on the analysis of the committed errors and the identification of quality-compromising behaviors, we are able to recommend important targets for learning in future training and simulation programs.
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              Ultrasound in regional anesthesia: where should the "focus" be set?


                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                07 February 2019
                : 12
                : 571-577
                [1 ]Department of Biomedical Engineering, University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA
                [2 ]Department of Anesthesiology, University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA, daryl_smith@ 123456urmc.rochester.edu
                [3 ]Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA
                Author notes
                Correspondence: Daryl I Smith, University of Rochester, School of Medicine and Dentistry, 601 Elmwood Avenue, Box 604 Rochester, NY 14641, USA, Tel +1 585 276 3770, E-mail daryl_smith@ 123456urmc.rochester.edu
                © 2019 Aziz et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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