title: Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem.
  
  
  METHODS
  This is a single centre study conducted at Queen's Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr-1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score).
  
  
  CONCLUSIONS
  Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration.
  
  
  BACKGROUND
  The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011).
  ISRCTN92946117. Registered 26 October 2012.
authors.affiliation: Department of Healthcare of Older People, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham NG7 2UH, UK. opinder.sahota@nuh.nhs.uk.
authors.forename: Opinder
authors.initials: O
authors.lastname: Sahota
authors.forename: Martin
authors.initials: M
authors.lastname: Rowlands
authors.forename: Jim
authors.initials: J
authors.lastname: Bradley
authors.forename: Gerrie
authors.initials: G
authors.lastname: Van de Walt
authors.forename: Nigel
authors.initials: N
authors.lastname: Bedforth
authors.forename: Sarah
authors.initials: S
authors.lastname: Armstrong
authors.forename: Iain
authors.initials: I
authors.lastname: Moppett
mesh_terms: D000368:Aged; D000577:Amides / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000779:Anesthetics, Local / Q000627:therapeutic use; D018771:Arthralgia / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005265:Femoral Neck Fractures / Q000150:complications*; D005267:Femoral Nerve / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000627:therapeutic use; D009407:Nerve Block / Q000379:methods*; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D012107:Research Design; D000077212:Ropivacaine
chemical_list: D000577:Amides; D000701:Analgesics, Opioid; D000779:Anesthetics, Local; D009020:Morphine; D000077212:Ropivacaine