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      Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial

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          Abstract

          Objectives

          We aimed to determine whether regional analgesia with intrathecal morphine (ITM) in an enhanced recovery programme (enhanced recovery after surgery [ERAS]) gives a shorter hospital stay with good pain relief and equal health-related quality of life (QoL) to epidural analgesia (EDA) in women after midline laparotomy for proven or assumed gynaecological malignancies.

          Design

          An open-label, randomised, single-centre study.

          Setting

          A tertiary referral Swedish university hospital.

          Participants

          Eighty women, 18–70 years of age, American Society of Anesthesiologists I and II, admitted consecutively to the department of Obstetrics and Gynaecology.

          Interventions

          The women were allocated (1:1) to either the standard analgesic method at the clinic (EDA) or the experimental treatment (ITM). An ERAS protocol with standardised perioperative routines and standardised general anaesthesia were applied. The EDA or ITM started immediately preoperatively. The ITM group received morphine, clonidine and bupivacaine intrathecally; the EDA group had an epidural infusion of bupivacaine, adrenalin and fentanyl.

          Primary and secondary outcome measures

          Primary endpoint was length of hospital stay (LOS). Secondary endpoints were QoL and pain assessments.

          Results

          LOS was statistically significantly shorter for the ITM group compared with the EDA group (median [IQR]3.3 [1.5–56.3] vs 4.3 [2.2–43.2] days; p=0.01). No differences were observed in pain assessment or QoL. The ITM group used postoperatively the first week significantly less opioids than the EDA group (median (IQR) 20 mg (14–35 mg) vs 81 mg (67–101 mg); p<0.0001). No serious adverse events were attributed to ITM or EDA.

          Conclusions

          Compared with EDA, ITM is simpler to administer and manage, is associated with shorter hospital stay and reduces opioid consumption postoperatively with an equally good QoL. ITM is effective as postoperative analgesia in gynaecological cancer surgery.

          Trial registration number

          NCT02026687; Results.

          Related collections

          Most cited references32

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          Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC.

          Here we provide the updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain. The update was undertaken by the European Palliative Care Research Collaborative. Previous EAPC guidelines were reviewed and compared with other currently available guidelines, and consensus recommendations were created by formal international expert panel. The content of the guidelines was defined according to several topics, each of which was assigned to collaborators who developed systematic literature reviews with a common methodology. The recommendations were developed by a writing committee that combined the evidence derived from the systematic reviews with the panellists' evaluations in a co-authored process, and were endorsed by the EAPC Board of Directors. The guidelines are presented as a list of 16 evidence-based recommendations developed according to the Grading of Recommendations Assessment, Development and Evaluation system. Copyright © 2012 Elsevier Ltd. All rights reserved.
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            Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice

            Background The present interdisciplinary consensus review proposes clinical considerations and recommendations for anaesthetic practice in patients undergoing gastrointestinal surgery with an Enhanced Recovery after Surgery (ERAS) programme. Methods Studies were selected with particular attention being paid to meta‐analyses, randomized controlled trials and large prospective cohort studies. For each item of the perioperative treatment pathway, available English‐language literature was examined and reviewed. The group reached a consensus recommendation after critical appraisal of the literature. Results This consensus statement demonstrates that anaesthesiologists control several preoperative, intraoperative and postoperative ERAS elements. Further research is needed to verify the strength of these recommendations. Conclusions Based on the evidence available for each element of perioperative care pathways, the Enhanced Recovery After Surgery (ERAS ®) Society presents a comprehensive consensus review, clinical considerations and recommendations for anaesthesia care in patients undergoing gastrointestinal surgery within an ERAS programme. This unified protocol facilitates involvement of anaesthesiologists in the implementation of the ERAS programmes and allows for comparison between centres and it eventually might facilitate the design of multi‐institutional prospective and adequately powered randomized trials.
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              The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden.

              We document the applicability of the SF-36 Health Survey, which was translated into Swedish using methods later adopted by the International Quality of Life Assessment (IQOLA) Project procedures. To test its appropriateness for use in Sweden, it was administered through mail-out/mail-back questionnaires in seven general population studies with an average response rate of 68%. The 8930 respondents varied by gender (48.2% men), age (range 15-93 years, mean age 42.7), marital status, education, socio-economic status, and geographical area. Psychometric methods used in the evaluation of the SF-36 in the U.S. were replicated. Over 90% of respondents had complete items for each of the eight SF-36 scales, although more missing data were observed for subjects 75 years and over. Scale scores could be computed for the vast majority of respondents (95% and over); slightly fewer in the oldest subgroup. Item-internal consistency was consistently high across socio-demographic subgroups and the eight scales. Most reliability estimates exceeded the 0.80 level. The highest reliability was observed for the Bodily Pain Scale where all subgroups met the 0.90 level recommended for individual comparisons; coefficients at or above 0.90 were also observed in most subgroups for the Physical Functioning Scale. Tests of scaling assumptions including hypothesized item groupings, which reflect the construct validity of scales, were consistently favorable across subgroups, although lower rates were noted in the oldest age group. In conclusion, these studies have yielded empirical evidence supporting the feasibility of a non-English language reproduction of the SF-36 Health Survey. The Swedish SF-36 is ready for further evaluation.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                4 March 2019
                : 9
                : 3
                : e024484
                Affiliations
                [1 ] departmentChildren and Women’s Health, Department of Clinical and Experimental Medicine , Linköping University , Linköping, Sweden
                [2 ] departmentDepartment of Obstetrics and Gynecology , Vrinnevisjukhuset i Norrkoping , Norrkoping, Sweden
                [3 ] departmentDepartment of Anesthesiology and Intensive Care, and Department of Medical and Health Sciences , Linköping University , Linköping, Sweden
                Author notes
                [Correspondence to ] Professor Preben Kjølhede; preben.kjolhede@ 123456liu.se
                Author information
                http://orcid.org/0000-0001-5702-4116
                Article
                bmjopen-2018-024484
                10.1136/bmjopen-2018-024484
                6430030
                30837253
                e57569c9-1900-4d6b-9c37-a05f28c7d180
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 28 May 2018
                : 06 January 2019
                : 28 January 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007687, Svenska Läkaresällskapet;
                Funded by: Region Östergötland and Linköping University;
                Funded by: Medical Reseach Council of South-east Sweden;
                Categories
                Obstetrics and Gynaecology
                Research
                1506
                Custom metadata
                unlocked

                Medicine
                regional analgesia,gynecological malignancy,laparotomy,opioid consumption,quality improvement

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