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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Opinder Sahota, Martin Rowlands, Jim Bradley, Gerrie Van de Walt, Nigel Bedforth, Sarah Armstrong, Iain Moppett

Published in: Trials | Issue 1/2014

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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/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.
Literature
1.
Wiles MD, Moran CG, Sahota O, Moppett IK: Nottingham Hip Fracture Score as a predictor of one year mortality in patients undergoing surgical repair of fractured neck of femur. Br J Anaesth. 2011, 106: 501-504. 10.1093/bja/aeq405.CrossRefPubMed
2.
Moppett IK, Parker M, Griffiths R, Bowers T, White SM, Moran CG: Nottingham hip fracture score: longitudinal and multi-assessment. Br J Anaesth. 2012, 109: 546-550. 10.1093/bja/aes187.CrossRefPubMed
3.
Currie CPM, Currie CPM, Plant F, Roberts J, Wakeman R, Williams A: The national hip fracture database national report 2012. 2012
4.
Fox KMMJ, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R: Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000, 11: 31-35. 10.1007/s001980050003.CrossRefPubMed
5.
Cuvillon P, Ripart J, Debureaux S, Boisson C, Veyrat E, Mahamat A, Bruelle P, Viel E, Eledjam JJ: Analgesia after hip fracture repair in elderly patients: the effect of a continuous femoral nerve block: a prospective and randomized study. Ann Fr Anesth Reanim. 2007, 26: 2-9. 10.1016/j.annfar.2006.06.025.CrossRefPubMed
6.
Fischer HB, Simanski CJ: A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005, 60: 1189-1202. 10.1111/j.1365-2044.2005.04382.x.CrossRefPubMed
7.
Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL: Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A: Biol Med Sci. 2003, 58: M76-M81. 10.1093/gerona/58.1.M76.CrossRef
8.
Morrison RS, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL: The impact of post-operative pain on outcomes following hip fracture. Pain. 2003, 103: 303-311. 10.1016/S0304-3959(02)00458-X.CrossRefPubMed
9.
Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H: A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008, 63: 1105-1123. 10.1111/j.1365-2044.2008.05565.x.CrossRefPubMed
10.
Parker M, Griffiths R, Appadu B: Nerve blocks (subcostal, lateral cutaneous, femoral, triple, psoas) for hip fractures. Cochrane Database Syst Rev. 2002, Issue 1. Art. No.: CD001159. doi:10.1002/14651858.CD001159.11
11.
Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H: Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007, 106: 773-778. 10.1097/01.anes.0000264764.56544.d2.CrossRefPubMed
12.
Hauritz RW, Gerlif C, Ronholm E: Fascia iliaca block performed by emergency department physician trainees in hip fractures. Ugeskr Laeger. 2009, 171: 515-518.PubMed
13.
Godoy Monzon D, Iserson KV, Vazquez JA: Single fascia iliaca compartment block for post-hip fracture pain relief. J Emerg Med. 2007, 32: 257-262. 10.1016/j.jemermed.2006.08.011.CrossRefPubMed
14.
Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A: Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012, 43: 692-697. 10.1016/j.jemermed.2012.01.050.CrossRefPubMed
15.
Beaudoin FL, Haran JP, Liebmann O: A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013, 20: 584-591. 10.1111/acem.12154.CrossRefPubMed
16.
Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H: Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005, 102: 1197-1204. 10.1097/00000542-200506000-00020.CrossRefPubMed
17.
Parker MJ, Palmer CR: A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993, 75: 797-798.PubMed
18.
David M, Colin C, Pam B, Alun C, James E, Richard G, Karen H, Anthony J, Alastair ML, Paul M, Martyn P, Opinder S, Andrew S, Anne S, Rob W: The care of patients with fragility fracture (The Blue Book). Book The Care of Patients with Fragility Fracture (The Blue Book). 2007, London: British Orthopaedic Association
19.
Metadata
Title
Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial
Authors
Opinder Sahota
Martin Rowlands
Jim Bradley
Gerrie Van de Walt
Nigel Bedforth
Sarah Armstrong
Iain Moppett
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-189

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