Femoral Nerve Blockage in Proximal Femoral Fractures in patients of 65 years of age or older, a Randomised Controlled Trial

With an average age of 81 years fractures of the hip are frequently seen in the
elderly (Court-Brown and Caesar, 2006). In this elder population three out of
four hip fractures occur in women and show an annual incidence of 793.5 per
100,000 in women and 368.0 in men (Holt et al., 2008; Wiles et al., 2011) Hip
fractures show high mortality rates up to 30% after 1 year (Wiles et al.,
2011). Moreover 4.5-14.3% of these vulnerable patients die during their
admission (Bottel and Aylin, 2006; Belmont et al. 2014).
Pain reduction is one of the main treatment goals in hip fractures. Primarily
for the patient*s comfort, but also to reduce complications and improve
rehabilitation. Patients with severe pain have a higher chance to develop a
delirium (morrisson et al.). Furthermore, pain is related with longer hospital
stays, delayed ambulation and persistent disabilities (Morrison et al., 2003;
Morrison et al., 2003). Controversially these frail patients are less likely to
receive pain medication in comparison to younger patients (Jones et al., 1996;
Platts-Mills et al., 1996).
Many different analgesics can nowadays be used to reduce pain. In many
institutes analgesics in trauma patients are chosen according to the WHO pain
ladder that was originally developed for cancer pain control (Vargas-Schaffer,
2010). According to this ladder mild pain is best treated with paracetamol and
shows little adverse events. The use of NSAIDs is frequently contraindicated in
the elder population due to gastrointestinal and renal complications, therefore
this step is skipped in most cases and opioids are prescribed (Holdgate et al.
2010). However, these opioids have several possible side effects. It is
therefore recommended to monitor patients on opioids for side-effects like
nausea, constipation and respiratory depression (Chau et al., 2008; Cepeda et
al., 2003).
Local anaesthetics can be a good additive or substitute for systemic analgesia
in trauma patients with a hip fracture (De Buck et al., 2012). At this moment
two different techniques are potentially suitable in hip fractures; fascia
iliaca compartment block (FICB) and femoral nerve blockage (FNB). However,
current literature for nerve blockage in hip fractures is scarce and
inconclusive. Furthermore, there is discussion on the best way to improve the
duration of the analgesia since single injection on admission might not be
adequate as they only provide analgesia for up to 24 hours. Therefore, it is
proposed to use a perineural catheter which allows prolonged delivery of local
anaesthetic (Sahota et al., 2014). However, these catheters are not used by
emergency physicians (EPs) and its usefulness might therefore be questionable.
We therefore propose to study the effect of a FNB after a hip fracture at
admission compared to a placebo injection regarding pain, complications and
functional outcome. If necessary, the FNB can be repeated to prolong the
duration of the analgesia.

The objective of this study is to determine the clinical outcomes of ultrasound
guided femoral nerve blockage using intermitting shots of levobupivacaine, in
patients with hip fractures and to compare these results with placebo
injections.
The primary objective is to investigate if femoral nerve blockage leads to a
decrease in pain and a decrease in complications (delirium, nausea, vomiting,
obstipation, hypotension, urinary retention, and respiratory depression). This
will be measured with the raw pain intensity difference up to 4 hours after the
femoral block. The percentage of patiënts with and without complications will
be recorded. Next we will record every individual complication.
The secondary objectives of this study include the pain measured with NRS on
multiple moments before and after surgery, the amount of analgesics used
(paracetamol, non-steroid anti-inflammatory drugs and opioids), length of
hospital stay, post-operative mobility status and subsequent discharge
location.

This is a double-blind randomized controlled trial. Participants will be
randomized into one of two arms: femoral nerve block with 0,25% Levobupivacaine
20ml or femoral nerve block with saline 20ml. Patient will be included into the
study immediately after radiographic confirmation of the hip fracture. Before
start of the study, the hospital pharmacy will perform randomization. Since the
study is double blind the hospital pharmacy will pack and blind the femoral
nerve blockage syringes supplied with a randomization number by a person not
affiliated with the project.

The emergency physician will perform the ultrasound guided femoral nerve block
with either Levobupivacaïne or plcebo sham injection.
If the patient is transferred to the nursing room, the nurse of the department
will measure NRS for pain. If necessary, the emergency physician will perform a
second femoral nerve block (with the blinded syringe containing the same
content as the first syringe). The second femoral nerve block will not be
performed before 6 hours after the first block.

The burden is highest during the femoral nerve blockage. This will comprise a
echo guided injection and will take a maximum of 15 minutes.
Asking NRS for pain is standard care. Physiotherapy in the first postoperative
days is standard care as well.