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      Serratus Anterior Plane Blocks for Early Rib Fracture Pain Management : The SABRE Randomized Clinical Trial

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          Abstract

          Importance

          Rib fractures secondary to blunt thoracic trauma typically result in severe pain that is notoriously difficult to manage. The serratus anterior plane block (SAPB) is a regional anesthesia technique that provides analgesia to most of the hemithorax; however, SAPB has limited evidence for analgesic benefits in rib fractures.

          Objective

          To determine whether the addition of an SAPB to protocolized care bundles increases the likelihood of early favorable analgesic outcomes and reduces opioid requirements in patients with rib fractures.

          Design, Setting, and Participants

          This multicenter, open-label, pragmatic randomized clinical trial was conducted at 8 emergency departments across metropolitan and regional New South Wales, Australia, between April 12, 2021, and January 22, 2022. Patients aged 16 years or older with clinically suspected or radiologically proven rib fractures were included in the study. Participants were excluded if they were intubated, transferred for urgent surgical intervention, or had a major concomitant nonthoracic injury. Data were analyzed from September 2022 to July 2023.

          Interventions

          Patients were randomly assigned (1:1) to receive an SAPB in addition to usual rib fracture management or standard care alone.

          Main Outcomes and Measures

          The primary outcome was a composite pain score measured 4 hours after enrollment. Patients met the primary outcome if they had a pain score reduction of 2 or more points and an absolute pain score of less than 4 out of 10 points.

          Results

          A total of 588 patients were screened, of whom 210 patients (median [IQR] age, 71 [55-84] years; 131 [62%] male) were enrolled, with 105 patients randomized to receive an SAPB plus standard care and 105 patients randomized to standard care alone. In the complete-case intention-to-treat primary outcome analysis, the composite pain score outcome was reached in 38 of 92 patients (41%) in the SAPB group and 18 of 92 patients (19.6%) in the control group (relative risk [RR], 0.73; 95% CI, 0.60-0.89; P = .001). There was a clinically significant reduction in overall opioid consumption in the SAPB group compared with the control group (eg, median [IQR] total opioid requirement at 24 hours: 45 [19-118] vs 91 [34-155] milligram morphine equivalents). Rates of pneumonia (6 patients [10%] vs 7 patients [11%]), length of stay (eg, median [IQR] hospital stay, 4.2 [2.2-7.7] vs 5 [3-7.3] days), and 30-day mortality (1 patient [1%] vs 3 patients [4%]) were similar between the SAPB and control groups.

          Conclusions and Relevance

          This randomized clinical trial found that the addition of an SAPB to standard rib fracture care significantly increased the proportion of patients who experienced a meaningful reduction in their pain score while also reducing in-hospital opioid requirements.

          Trial Registration

          http://anzctr.org.au Identifier: ACTRN12621000040864

          Related collections

          Most cited references32

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          When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts

          Background Missing data may seriously compromise inferences from randomised clinical trials, especially if missing data are not handled appropriately. The potential bias due to missing data depends on the mechanism causing the data to be missing, and the analytical methods applied to amend the missingness. Therefore, the analysis of trial data with missing values requires careful planning and attention. Methods The authors had several meetings and discussions considering optimal ways of handling missing data to minimise the bias potential. We also searched PubMed (key words: missing data; randomi*; statistical analysis) and reference lists of known studies for papers (theoretical papers; empirical studies; simulation studies; etc.) on how to deal with missing data when analysing randomised clinical trials. Results Handling missing data is an important, yet difficult and complex task when analysing results of randomised clinical trials. We consider how to optimise the handling of missing data during the planning stage of a randomised clinical trial and recommend analytical approaches which may prevent bias caused by unavoidable missing data. We consider the strengths and limitations of using of best-worst and worst-best sensitivity analyses, multiple imputation, and full information maximum likelihood. We also present practical flowcharts on how to deal with missing data and an overview of the steps that always need to be considered during the analysis stage of a trial. Conclusions We present a practical guide and flowcharts describing when and how multiple imputation should be used to handle missing data in randomised clinical. Electronic supplementary material The online version of this article (10.1186/s12874-017-0442-1) contains supplementary material, which is available to authorized users.
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            A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D

            Background Since the introduction of the five-level version of the EQ-5D (5L), many studies have comparatively investigated the measurement properties of the original three-level version (3L) with the 5L version. Objective The aim of this study was to consolidate the available evidence on the performance of both instruments. Methods A systematic literature search of studies in the English and German languages was conducted (2007–January 2018) using the PubMed, EMBASE, and PsycINFO (EBSCO) databases, as well as the EuroQol Research Foundation website. Data were extracted and assessed on missing values, distributional properties, informativity indices (Shannon’s H′ and J′), inconsistencies, responsiveness, and test–retest reliability. Results Twenty-four studies were included in the review. Missing values and floor effects (percentage reporting the worst health state) were found to be negligible for both 3L and 5L (< 5%). From 18 studies, inconsistencies ranged from 0 to 10.6%, although they were generally well below 5%, with 9 studies reporting the most inconsistencies for Usual Activities (mean percentage 4.1%). Shannon’s indices were always higher for 5L than for 3L, and all but three studies reported lower ceiling effects (‘11111’) for 5L than for 3L. There is mixed and insufficient evidence on responsiveness and test–retest reliability, although results on index values showed better performance for 5L on test–retest reliability. Conclusion Overall, studies showed similar or better measurement properties of the 5L compared with the 3L, and evidence indicated moderately better distributional parameters and substantial improvement in informativity for the 5L compared with the 3L. Insufficient evidence on responsiveness and test–retest reliability implies further research is needed. Electronic supplementary material The online version of this article (10.1007/s40273-018-0642-5) contains supplementary material, which is available to authorized users.
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              Elderly trauma patients with rib fractures are at greater risk of death and pneumonia.

              The purpose of this study was to show that elderly patients admitted with rib fractures after blunt trauma have increased mortality. Demographic, injury severity, and outcome data on a cohort of consecutive adult trauma admissions with rib fractures to a tertiary care trauma center from April 1, 1993, to March 31, 2000, were extracted from our trauma registry. Among 4,325 blunt trauma admissions, there were 405 (9.4%) patients with rib fractures; 113 were aged > or = 65. Injuries were severe, with Injury Severity Score (ISS) > or = 16 in 54.8% of cases, a mean hospital stay of 26.8 +/- 43.7 days, and 28.6% of patients requiring mechanical ventilation. Mortality (19.5% vs. 9.3%; p or = 65 despite significantly lower ISS (p = 0.031), higher Glasgow Coma Scale score (p = 0.0003), and higher Revised Trauma Score (p or = 65 had five times the odds of dying when compared with those < 65 years old. Despite lower indices of injury severity, even after taking account of comorbidities, mortality was significantly increased in elderly patients admitted to a trauma center with rib fractures.
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                Author and article information

                Journal
                JAMA Surgery
                JAMA Surg
                American Medical Association (AMA)
                2168-6254
                May 01 2024
                Affiliations
                [1 ]Emergency Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia
                [2 ]Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
                [3 ]Aeromedical Operations, NSW Ambulance, Bankstown Aerodrome, New South Wales, Australia
                [4 ]Emergency Department, St George Hospital, Sydney, New South Wales, Australia
                [5 ]St George & Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia
                [6 ]Emergency Department, Orange Base Hospital, Orange, New South Wales, Australia
                [7 ]RPA Virtual Hospital, Sydney, New South Wales, Australia
                [8 ]Orange Clinical School, University of Sydney, Orange, New South Wales, Australia
                [9 ]Emergency Department, Liverpool Hospital, Liverpool, New South Wales, Australia
                [10 ]South West Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
                [11 ]Emergency Department, Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia
                [12 ]Discipline of Emergency Medicine, University of Sydney, Sydney, New South Wales, Australia
                [13 ]Emergency Department, The Sutherland Hospital, Caringbah, Sydney, New South Wales, Australia
                [14 ]Emergency Department, Campbelltown and Camden Hospitals, Campbelltown, New South Wales, Australia
                [15 ]School of Medicine, University of Western Sydney, Campbelltown, New South Wales, Australia
                [16 ]Emergency Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
                [17 ]Trauma Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
                [18 ]Greenlight Institute, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
                [19 ]School of Rural Health, Sydney Medical School, University of Sydney, Orange, New South Wales, Australia
                [20 ]Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, New South Wales, Australia
                [21 ]Division of Critical Care, The George Institute of Global Health, University of New South Wales, Sydney, Australia
                [22 ]Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, Victoria, Australia
                [23 ]George Institute for Global Health, Sidney, New South Wales, Australia
                [24 ]Critical Care Research, Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia
                Article
                10.1001/jamasurg.2024.0969
                82906835-c934-4755-8675-80f142c8cc30
                © 2024
                History

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