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.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN46621916. EudraCT 2011-005775-16.
authors.affiliation: Department of Anaesthesia, Royal Cornwall Hospital, Truro, UK.
authors.forename: R
authors.initials: R
authors.lastname: Langford
authors.affiliation: Department of Surgery, Royal Cornwall Hospital, Truro, UK.
authors.forename: I
authors.initials: I
authors.lastname: Brown
authors.affiliation: Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
authors.forename: J
authors.initials: J
authors.lastname: Vickery
authors.affiliation: Department of Anaesthesia, Royal Cornwall Hospital, Truro, UK.
authors.forename: K
authors.initials: K
authors.lastname: Mitchell
authors.affiliation: NIHR Research Design Service (South West), Truro, UK.
authors.forename: C
authors.initials: C
authors.lastname: Pritchard
authors.affiliation: Centre for Biostatistics, Bioinformatics & Biomarkers, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
authors.forename: S
authors.initials: S
authors.lastname: Creanor
mesh_terms: D016058:Analgesia, Patient-Controlled / Q000379:methods*; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000627:therapeutic use; D002045:Bupivacaine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods; D000077554:Levobupivacaine; D008408:Mastectomy / Q000009:adverse effects*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D011788:Quality of Life; D012782:Shoulder / Q000502:physiology*
chemical_list: D000779:Anesthetics, Local; D000077554:Levobupivacaine; D002045:Bupivacaine
keywords: Anaesthetic infusion; Local Anaesthetic; Mastectomy; Pain; Shoulder function