Abstract
BackgroundHip 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/DesignThis 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).DiscussionMany 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.Trial registrationThe trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011). ISRCTN: ISRCTN92946117. Registered 26 October 2012.
Highlights
Hip fractures are very painful leading to lengthy hospital stays
This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration
Primary aims The primary aim of this study is to investigate if early use of femoral nerve blockade, with subsequent insertion of a femoral nerve catheter and an infusion of local anaesthetic, results in an increase in cumulative mobility score and a decrease in cumulative dynamic pain score in the first three postoperative days after surgery for a fractured neck of femur
Summary
Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Hip fractures remain one of the most serious injuries that occur in older people [1,2,3], with a mortality rate of 10% at one month, 20% at four months and 30% at one year [4]. Many of those who recover suffer a loss in mobility and independence. Current methods of providing analgesia include: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), oral or parenteral opioids, and regional anaesthesia techniques.
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