Title: The FINOF(Femoral Nerve-Block Intervention in Neck Of Femur Fracture) Study
Funder: Department of Health (England)

Abstract: Background There are 75,000 hip fractures in the UK each year. These fractures are painful and traditionally patients require systemic opioids, which although effective, have undesired adverse events. These include nausea, vomiting, constipation and infrequently, but importantly, delirium. In some patients, post operative analgesia is suboptimal. This leads to further complications, impaired rehabilitation and prolonged hospital stay. Regional anaesthetic techniques, have been proposed as an alternative and practical method of alleviating both rest and dynamic pain. Femoral nerve blockade may be the optimal technique, however no study has examined the effects of pre operative block, followed by continuous femoral nerve blockade on pain, rehabilitation, and content / process fidelity. Aims The hypothesis to be tested is that femoral nerve block administered in the acute and early post operative phase to elderly hip fracture participants will control pain, improve early rehabilitation and reduce opioid associated complications. The aims of this study are to : 1. evaluate the effects of femoral nerve block compared to systemic opioids upon pain in the acute & post operative phase and post operative rehabilitation. 2. estimate the cost-effectiveness of femoral nerve block, compared to usual care from a NHS perspective. 3. examine issues of compliance, acceptability to staff and patients and systems implementation (content and process fidelity) to enable replication of the findings of this study to other hospital settings. Plan of Investigation A 12 month, randomised controlled trial. Elderly patients presenting to the hospital with a suspected low trauma hip fracture will be randomised to the study analgesia protocol or standard analgesia care. The study analgesia protocol will include, a femoral nerve block, followed by insertion of a peri-neural femoral nerve catheter and femoral nerve blockade maintained by infusion for 72hrs post-operatively. Primary outcome will be a cumulative day1 to day 3 post operative dynamic pain score and cumulative rehabilitation score. A detailed integral qualitative study will be undertaken (subset of participants) to examine content and process fidelity. Potential Impact It is hypothesised that femoral nerve block in acute hip fracture care is a safe and effective method of pain control. This will avoid the use of systemic opioids which are associated with significant adverse effects, particularly in the more frail, elderly patient. Continuous nerve block will ensure optimal rest and dynamic pain control and will be easy to administer in all participants. This will lead to fewer opioid related complications, earlier recovery, shorter length of stay in hospital and overall, improved quality of life compared to the standard analgesia regime. The qualitative part of the study will enable better understanding of the content and process fidelity which are important for widespread implementation of the study findings.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INJURIES AND ACCIDENTS