Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial

Trials

Iain Moppett¹  Sarah Armstrong³  Nigel Bedforth⁴  Gerrie Van de Walt⁴  Jim Bradley⁴  Martin Rowlands¹  Opinder Sahota² 

[1] Anaesthesia and Critical Care Research Group, Division of Clinical Neuroscience, University of Nottingham, Queen’s Medical Centre, Derby Road, Nottingham, UK;Department of Healthcare of Older People, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham NG7 2UH, UK;NIHR Research Design Service for the East Midlands, Faculty of Medicine & Health Sciences, University of Nottingham, Queen’s Medical Centre, Derby Road, Nottingham NG7 2UH, UK;Queen’s Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham NG7 2UH, UK

关键词: Nerve block;    Femoral nerve catheter;    Femoral nerve block;    Analgesia;    Hip surgery;    Hip fracture;    Elderly;   

Others  :  805670
DOI  :  10.1186/1745-6215-15-189

 received in 2013-11-15, accepted in 2014-05-15,  发布年份 2014

【 摘 要 】

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/Design

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).

Discussion

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.

Trial registration

The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011). ISRCTN: ISRCTN92946117. Registered 26 October 2012.

【 授权许可】

   
2014 Sahota et al.; licensee BioMed Central Ltd.

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