title: Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Thoracic epidural analgesia (TEA) is recommended for post-operative pain relief in patients undergoing major abdominal surgery via a midline incision. However, the effectiveness of TEA is variable with high failure rates reported post-operatively. Common side effects such as low blood pressure and motor block can reduce mobility and hinder recovery, and a number of rare but serious complications can also occur following their use.Rectus sheath catheters (RSC) may provide a novel alternative approach to somatic analgesia without the associated adverse effects of TEA. The aim of this study is to compare the efficacy of both techniques in terms of pain relief, patient experience, post-operative functional recovery, safety and cost-effectiveness.
  
  
  METHODS
  This is a single-centre randomised controlled non-blinded trial, which also includes a nested qualitative study. Over a two-year period, 132 patients undergoing major abdominal surgery via a midline incision will be randomised to receive either TEA or RSC for post-operative analgesia. The primary outcome measures pain scores on moving from a supine to a sitting position at 24 hours post wound closure, and the patient experience between groups evaluated through in-depth interviews. Secondary outcomes include pain scores at rest and on movement at other time points, opiate consumption, functional recovery, morbidity and cost-effectiveness.
  
  
  CONCLUSIONS
  This will be the first randomised controlled trial comparing thoracic epidurals to ultrasound-guided rectus sheath catheters in adults undergoing elective midline laparotomy. The standardised care provided by an Enhanced Recovery Programme makes this a comparison between two complex pain packages and not simply two analgesic techniques, in order to ascertain if RSC is a viable alternative to TEA.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN81223298 (16 January 2014).
authors.forename: Kate M
authors.initials: KM
authors.lastname: Wilkinson
authors.affiliation: Department of Anaesthesia and Critical Care, Royal Blackburn Hospital, Blackburn BB2 3HH, UK. anton.krige@elht.nhs.uk.
authors.forename: Anton
authors.initials: A
authors.lastname: Krige
authors.forename: Sarah G
authors.initials: SG
authors.lastname: Brearley
authors.forename: Steven
authors.initials: S
authors.lastname: Lane
authors.forename: Michael
authors.initials: M
authors.lastname: Scott
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Gordon
authors.forename: Gordon L
authors.initials: GL
authors.lastname: Carlson
mesh_terms: D000005:Abdomen / Q000601:surgery*; D015746:Abdominal Pain / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D015360:Analgesia, Epidural / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D000701:Analgesics, Opioid / Q000627:therapeutic use; D057785:Catheters / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D004867:Equipment Design; D017048:Health Care Costs; D006801:Humans; D007407:Interviews as Topic; D009407:Nerve Block / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D059408:Pain Management / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D017060:Patient Satisfaction; D036301:Qualitative Research; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid