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      Intrathecal hyperbaric versus isobaric bupivacaine for adult non-caesarean-section surgery: systematic review protocol

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          Abstract

          Introduction

          Bupivacaine is the most commonly used local anaesthetic for spinal anaesthesia (SA). There are two forms of commercially available bupivacaine; isobaric bupivacaine (IB): a formulation with a specific gravity or density equal to cerebrospinal fluid, and hyperbaric bupivacaine (HB): a formulation with density heavier than cerebrospinal fluid. The difference in densities of the two available preparations is believed to affect the diffusion pattern that determines the effectiveness, spread and side-effect profile of bupivacaine. This systematic review will summarise the best available evidence regarding the effectiveness and safety on the use of HB compared with IB, when used to provide SA for surgery. Primarily, we will analyse the need for conversion to general anaesthesia. As secondary outcomes, we will compare the incidence of hypotension, incidence of nausea/vomiting, the onset time and duration of anaesthesia.

          Methods and analysis

          We will search key electronic databases using search strategy (1) injections, spinal OR intrathecal OR subarachnoid; (2) bupivacaine OR levobupivacaine; (3) hypobaric OR isobaric OR plain; (4) baricity. We will search MEDLINE, EMBASE and Cochrane databases, from their inception for randomised controlled trials, with no restrictions on language. Caesarean section surgery will be excluded. 2 reviewers will independently extract the data using a standardised form. Extracted items will include study characteristics, risk of bias domains, as per modified Cochrane risk of bias, participant disposition and study outcomes. We will conduct a meta-analysis for variables that can be compared across the studies. We will evaluate clinical heterogeneity by qualitatively appraising differences in study characteristics in participants, interventions and the outcomes assessed. We will report our findings as relative risks (dichotomous), and weighted mean differences (continuous) for individual outcomes, along with their 95% CIs.

          Ethics and dissemination

          We plan to submit, and will publish, our findings in a peer-reviewed scientific journal, and present our results at national and international meetings.

          Trial registration number

          CRD42015017672.

          Related collections

          Most cited references19

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          Statistical heterogeneity in systematic reviews of clinical trials: a critical appraisal of guidelines and practice.

          Heterogeneity between study results can be a problem in any systematic review or meta-analysis of clinical trials. Identifying its presence, investigating its cause and correctly accounting for it in analyses all involve difficult decisions for the researcher. Our objectives were: to collate recommendations on the subject of dealing with heterogeneity in systematic reviews of clinical trials; to investigate current practice in addressing heterogeneity in Cochrane reviews; and to compare current practice with recommendations. We review guidelines for those undertaking systematic reviews and examine how heterogeneity is addressed in practice in a sample of systematic reviews, and their protocols, from the Cochrane Database of Systematic Reviews. Advice to reviewers is on the whole consistent and sensible. However, examination of a sample of Cochrane protocols and reviews demonstrates that the advice is difficult to follow given the small numbers of studies identified in many systematic reviews, the difficulty of pre-specifying important effect modifiers for subgroup analysis or meta-regression and the unresolved debate concerning fixed versus random effects meta-analyses. There was disagreement between protocols and reviews, often either regarding choice of important potential effect modifiers or due to the review identifying too few studies to perform planned analyses. Guidelines that address practical issues are required to reduce the risk of spurious findings from investigations of heterogeneity. This may involve discouraging statistical investigations such as subgroup analyses and meta-regression, rather than simply adopting a cautious approach to their interpretation, unless a large number of studies is available. The notion of a priori specification of potential effect modifiers for a retrospective review of studies is ill-defined, and the appropriateness of using a statistical test for heterogeneity to decide between analysis strategies is suspect.
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            Distribution of local anesthetic solutions within the subarachnoid space.

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              Intrathecal bupivacaine in humans: influence of volume and baricity of solutions.

              The effects of volume and baricity of spinal bupivacaine on block onset, height, duration, and hemodynamics were studied. Ninety patients undergoing endoscopic urologic procedures were randomized to receive 10 mg of intrathecal bupivacaine at L2-L3 level in sitting position. In the operating room, commercial products were diluted as needed with NaCl 0.9% to obtain isobaric solutions (density, 1.005-1.008) or with NaC 10.9% and glucose 30% to obtain hyperbaric solutions (density, 1.031-1.037) of 2, 5, or 10 ml (six groups of 15 patients each). Three minutes after spinal injection the patients were placed in lithotomy position. Sensory blockade was assessed using pinprick and cold sensation tests, and motor blockade was assessed using a four-point scale. Onset times to maximal cephalad spread of spinal blockade were similar with isobaric and hyperbaric solutions. A greater maximal cephalad spread of anesthesia was obtained with diluted isobaric bupivacaine but was not associated with more hypotension. Volume had no effect on cephalad extent of anesthesia with hyperbaric bupivacaine. Times for regression of anesthesia to L2 and offset of motor block were longer with isobaric than with hyperbaric solutions of bupivacaine. The intensity of motor blockade was decreased with diluted hyperbaric bupivacaine. No patient reported back pain. In this study, volume had no significant influence on either cephalad spread or duration of sensory blockade for either isobaric or hyperbaric bupivacaine. Time for offset of anesthesia was shorter with hyperbaric bupivacaine compared with isobaric solutions.
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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
                2016
                18 May 2016
                : 6
                : 5
                : e010885
                Affiliations
                [1 ]Dalhousie Department of Anesthesia, Perioperative Medicine and Pain Management, Nova Scotia Health Authority and IWK Health Centre , Halifax, Nova Scotia, Canada
                [2 ]Department of Anesthesia, McMaster University, St Joseph's Health Care , Hamilton, Ontario, Canada
                [3 ]Department of Anesthesia, University of British Columbia, St. Paul's Hospital , Vancouver, British Columbia, Canada
                Author notes
                [Correspondence to ] Dr Vishal Uppal; v.uppal@ 123456dal.ca
                Article
                bmjopen-2015-010885
                10.1136/bmjopen-2015-010885
                4874203
                27194318
                52351ce1-d5c9-4471-a40f-2da0e23485ed
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 16 December 2015
                : 21 March 2016
                : 19 April 2016
                Categories
                Anaesthesia
                Protocol
                1506
                1682
                1694

                Medicine
                spinal anesthesia,hyperbaric bupivacaine,isobaric bupivacaine,levobupivacinaine,non-caesarean-section surgery

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