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      The Statistical Analyses Of The Study “Sufentanil Sublingual Tablet System (SSTS) For The Management Of Postoperative Pain After Major Abdominal And Gynecological Surgery Within An ERAS Protocol: An Observational Study” [Response To Letter]

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          Abstract

          Dear editor We thank Wang and Miao1 for their interest in our recent publication2 and the appreciation of our work. We agree with them on the need of using repeated-measures analysis to evaluate pain intensity at different timepoints. We acknowledge that, for the sake of brevity, our manuscript did not properly clarify the statistical methods used for the analysis and we take this opportunity to better explain them. We performed a repeated measure analysis of variance (ANOVA) to compare pain intensity on different time points. The analysis resulted statistically significant (p<0.01). Afterwards, we performed multiple comparisons using the error deriving from the ANOVA for repeated measures, which turned out statistically significant (p<0.01). In addition, we used the paired t-test to compare pain intensity on day 0 (baseline) and day 3, as indicated in the recent publication (median NRS 6 to 0, p<0.01).2

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          Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study

          Background The Sufentanil Sublingual Tablet System (SSTS) is a new, pre-programmed, noninvasive, handheld system for patient-controlled analgesia (PCA) which may allow a faster postoperative recovery compared with standard PCA. The efficacy of SSTS in controlling pain after open abdominal surgery has already been documented. However, to our knowledge SSTS has never been investigated in patients undergoing major surgery within an Enhanced Recovery After Surgery (ERAS) protocol. Methods This observational, retrospective analysis included consecutive patients undergoing elective major abdominal and gynecological surgery. All patients received the SSTS device once they were fully awake and had a good control of pain at the end of the surgery. We analyzed changes in pain intensity according to the numerical rating scale (NRS) throughout the treatment as well as its duration, the number of administrations, and possible related adverse events. Patients were also interviewed to assess their quality of sleep and overall satisfaction with the SSTS device. Results The study included 308 patients. Compared to the first SSTS administration, pain intensity decreased from a median NRS of 6 to 0 at day 3, for an overall reduction of 79%. Results were already statistically significant at postoperative day 1 (p<0.01). Adverse reactions were observed in 62 patients, with nausea being the most frequent (12%), and in 93% of patients SSTS was discontinued because it was considered no longer necessary. Patient satisfaction was high, with 89% of them judging the device as “easy” or “very easy” to use. Conclusions Although the retrospective and observational nature of the study as well as the absence of a comparative group limits the strength of evidence, our results consider SSTS an effective and safe tool for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol.
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            The statistical analyses of the study “Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study”[Letter]

            Dear editor We read the observational study “Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study” of Stefano Turi et al.1 published in August 2019, Volume 12, p2313–2319 with great pleasure. I think that the findings detected in this study will contribute to the clinical practice. However, the statistical analyses were not appropriate. In the "Data analysis" section, the authors stated that "Pain intensity was calculated as the mean NRS value at first administration (baseline, V0), and during the following 24, 48, and 72 hrs (V1, V2, and V3, respectively). Pain intensity at different timepoints was compared using the Student’s t-test". The effect of time should be considered by the authors to measure the NRS value at each pre-determined assessment time. Therefore, we think the pain intensity at different timepoints should be analyzed using a repeated-measures analysis.
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              Author and article information

              Journal
              J Pain Res
              J Pain Res
              JPR
              jpainres
              Journal of Pain Research
              Dove
              1178-7090
              03 October 2019
              2019
              : 12
              : 2815-2816
              Affiliations
              [1 ]Dipartimento di Anestesia, Ospedale San Raffaele , Milano, Italy
              Author notes
              Correspondence: Stefano Turi Department of Anesthesiology, Vita-Salute, University, San Raffaele Hospital , Via Olgettina 60, Milan20132, ItalyTel + 39 02 2 643 2656 Email turi.stefano@hsr.it
              Article
              230945
              10.2147/JPR.S230945
              6781594
              © 2019 Turi 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. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

              Page count
              References: 2, Pages: 2
              Categories
              Response to Letter

              Anesthesiology & Pain management

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