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dc.contributor.authorLangford, R
dc.contributor.authorBrown, I
dc.contributor.authorVickery, J
dc.contributor.authorMitchell, K
dc.contributor.authorPritchard, C
dc.contributor.authorCreanor, S
dc.date.accessioned2015-07-03T14:14:54Z
dc.date.available2015-07-03T14:14:54Z
dc.date.issued2014-09
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.urihttp://hdl.handle.net/10026.1/3409
dc.description.abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>Over 16 000 mastectomies are performed in England and Wales annually. Acute postoperative pain and nausea are common. The most frequently occurring long-term complications are chronic pain (up to 50%) and reduced shoulder function (reported at 35%). Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications. This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a randomised, double blind, placebo-controlled, two-centre, parallel group trial in women undergoing mastectomy with or without axillary involvement. One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25% levobupivacaine or 0.9% saline by subpectoral infusion postoperatively for 24 h. All participants will be provided with an intravenous morphine patient-controlled analgesia (PCA) system. Participants will be followed-up for 24 h in hospital and at approximately 14 days and 6 months postoperatively. Joint primary outcome measures are total morphine consumption and total pain score (captured via patient-recorded visual analogue scale (VAS) 4 hourly) during the first 24 h postoperatively. Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph. Secondary outcomes include PCA attempts in first 24 h; VAS pain scores and shoulder function by goniometry at 24 h, 14 days (approximately) and 6 months; Verbal Rating Scale pain scores in first 24 h; Brief Pain Inventory and Oxford Shoulder Score at 6 months; duration of hospital stay; incidence of postoperative nausea and vomiting; cost-effectiveness.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study is approved by the South West England Research Ethics Committee (12/SW/0149).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>will be published in a peer-reviewed journal and presented at local, national and international scientific meetings.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>ISRCTN46621916. EudraCT 2011-005775-16.</jats:p></jats:sec>

dc.format.extente006318-e006318
dc.format.mediumElectronic
dc.languageen
dc.language.isoeng
dc.publisherBMJ
dc.subjectAnaesthetic infusion
dc.subjectLocal Anaesthetic
dc.subjectMastectomy
dc.subjectPain
dc.subjectShoulder function
dc.subjectAnalgesia, Patient-Controlled
dc.subjectAnesthetics, Local
dc.subjectBupivacaine
dc.subjectClinical Protocols
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectHumans
dc.subjectInfusions, Intravenous
dc.subjectLevobupivacaine
dc.subjectMastectomy
dc.subjectPain Measurement
dc.subjectPain, Postoperative
dc.subjectQuality of Life
dc.subjectShoulder
dc.titleStudy protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study
dc.typejournal-article
dc.typeJournal Article
dc.typeMulticenter Study
dc.typeRandomized Controlled Trial
dc.typeResearch Support, Non-U.S. Gov't
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/25270861
plymouth.issue9
plymouth.volume4
plymouth.publisher-urlhttp://dx.doi.org/10.1136/bmjopen-2014-006318
plymouth.publication-statusPublished
plymouth.journalBMJ Open
dc.identifier.doi10.1136/bmjopen-2014-006318
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Health and Community
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBBB
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS
dc.publisher.placeEngland
dcterms.dateAccepted2014-09-05
dc.identifier.eissn2044-6055
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.1136/bmjopen-2014-006318
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.typeJournal Article/Review


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