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      Continuous erector spinae plane block versus intercostal nerve block in patients undergoing video-assisted thoracoscopic surgery: a pilot randomized controlled trial

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          Abstract

          Background

          The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. Intercostal nerve blockade (ICNB) is limited by its duration of action. The erector spinae plane (ESP) block has the potential to provide satisfactory analgesia for VATS; however, the effectiveness of continuous ESP versus surgeon-performed ICNB has not been investigated. The objectives of this study were to establish feasibility of patient recruitment and follow-up before undertaking a fully powered randomized controlled trial (RCT); and, secondarily, to compare opioid usage, pain control, and sensory blockade.

          Methods

          This feasibility RCT was undertaken at St Joseph’s Hospital, Hamilton, Ontario, Canada, and included 24 patients (>18 years) having elective VATS with at least one overnight stay. Exclusion criteria were patient refusal, body mass index >40 kg/m 2, contraindications to neuraxial analgesia techniques as per the American Society of Regional Anesthesia and Pain guidelines, known allergy to local anesthetics, language or comprehension barriers, procedures with a higher chance of open surgery, and regular opioid use for ≥3 months preoperatively. Patients underwent either continuous ESP ( n=12) or surgeon-performed ICNB ( n=12). All patients received routine intraoperative anesthesia care and multimodal analgesia. Feasibility criteria were recruitment rate of two patients/week and full follow-up in all patients in-hospital. We compared opioid consumption, postoperative pain scores (0–10 numerical rating scale), adverse events, patient satisfaction, and distribution of sensory blockade as clinical outcomes (secondary).

          Results

          Feasibility of primary outcomes was successfully demonstrated. Five patients had an epidural in anticipation of open surgery. Mean opioid consumption as equivalent morphine units was less in the ESP group over the first 24 h (mean difference, 1.63 [95% CI –1.20 to 4.45]) and 48 h (mean difference, 2.34 [95% CI –1.93 to 6.61]). There were no differences in adverse effects.

          Conclusions

          A fully powered RCT is feasible with modifications. Our results also suggest that continuous ESP is safe and can decrease opioid needs. However, it is important to consider procedures to improve compliance to protocol and adherence to assigned interventions.

          Trial registration

          Clinicaltrials.gov identifier: NCT03176667. Registered June 5, 2017.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40814-021-00801-7.

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          Most cited references28

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          Sample size of 12 per group rule of thumb for a pilot study

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            CONSORT 2010 statement: extension to randomised pilot and feasibility trials

            The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.
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              The Erector Spinae Plane Block

              Thoracic neuropathic pain is a debilitating condition that is often poorly responsive to oral and topical pharmacotherapy. The benefit of interventional nerve block procedures is unclear due to a paucity of evidence and the invasiveness of the described techniques. In this report, we describe a novel interfascial plane block, the erector spinae plane (ESP) block, and its successful application in 2 cases of severe neuropathic pain (the first resulting from metastatic disease of the ribs, and the second from malunion of multiple rib fractures). In both cases, the ESP block also produced an extensive multidermatomal sensory block. Anatomical and radiological investigation in fresh cadavers indicates that its likely site of action is at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block holds promise as a simple and safe technique for thoracic analgesia in both chronic neuropathic pain as well as acute postsurgical or posttraumatic pain.
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                Author and article information

                Contributors
                shanthh@mcmaster.ca
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                24 February 2021
                24 February 2021
                2021
                : 7
                : 56
                Affiliations
                [1 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Department of Anesthesia, , McMaster University, ; Hamilton, Ontario Canada
                [2 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Department of Surgery, , McMaster University, ; Hamilton, Ontario Canada
                [3 ]Department of Anesthesia, St. Joseph’s Health Care Hamilton, Hamilton, Ontario Canada
                [4 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Health Research Methods, Evidence and Impact, , McMaster University, ; Hamilton, Ontario Canada
                Author information
                http://orcid.org/0000-0002-4105-4465
                Article
                801
                10.1186/s40814-021-00801-7
                7903734
                33627193
                73cbc719-429e-4b9f-9954-5ea798436f90
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 18 August 2020
                : 16 February 2021
                Funding
                Funded by: Regional Medical Association, McMaster University
                Funded by: Canadian Anesthesia Research Foundation
                Categories
                Research
                Custom metadata
                © The Author(s) 2021

                erector spinae plane block,intercostal nerve blockade,perioperative analgesia,video-assisted thoracoscopic surgery

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