Study 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.contributor.author | Langford, R | en |
dc.contributor.author | Brown, I | en |
dc.contributor.author | Vickery, J | en |
dc.contributor.author | Mitchell, K | en |
dc.contributor.author | Pritchard, C | en |
dc.contributor.author | Creanor, S | en |
dc.date.accessioned | 2015-07-03T14:14:54Z | |
dc.date.available | 2015-07-03T14:14:54Z | |
dc.date.issued | 2014-09-30 | en |
dc.identifier.uri | http://hdl.handle.net/10026.1/3409 | |
dc.description.abstract |
INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: The study is approved by the South West England Research Ethics Committee (12/SW/0149). RESULTS: will be published in a peer-reviewed journal and presented at local, national and international scientific meetings. TRIAL REGISTRATION: ISRCTN46621916. EudraCT 2011-005775-16. | en |
dc.format.extent | e006318 - ? | en |
dc.language | eng | en |
dc.language.iso | eng | en |
dc.subject | Anaesthetic infusion | en |
dc.subject | Local Anaesthetic | en |
dc.subject | Mastectomy | en |
dc.subject | Pain | en |
dc.subject | Shoulder function | en |
dc.subject | Analgesia, Patient-Controlled | en |
dc.subject | Anesthetics, Local | en |
dc.subject | Bupivacaine | en |
dc.subject | Clinical Protocols | en |
dc.subject | Double-Blind Method | en |
dc.subject | Female | en |
dc.subject | Humans | en |
dc.subject | Infusions, Intravenous | en |
dc.subject | Levobupivacaine | en |
dc.subject | Mastectomy | en |
dc.subject | Pain Measurement | en |
dc.subject | Pain, Postoperative | en |
dc.subject | Quality of Life | en |
dc.subject | Shoulder | en |
dc.title | Study 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. | en |
dc.type | Journal Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/25270861 | en |
plymouth.issue | 9 | en |
plymouth.volume | 4 | en |
plymouth.publication-status | Published online | en |
plymouth.journal | BMJ Open | en |
dc.identifier.doi | 10.1136/bmjopen-2014-006318 | en |
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.place | England | en |
dc.identifier.eissn | 2044-6055 | en |
dc.rights.embargoperiod | Not known | en |
rioxxterms.versionofrecord | 10.1136/bmjopen-2014-006318 | en |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | en |
rioxxterms.type | Journal Article/Review | en |