MORphine use in the Fascia Iliaca Compartment block with UltraSound

Appropriate management of analgesia for proximal femur fracture is a common
problem in the emergency department (ED). Side effects are especially
pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as
a simple and safe, and effective method to reduce pain. Local anesthetic
injected in the anatomic space underlying the fascia iliaca, spreads to block
the nerves traversing it. This regional anesthesia includes the femoral nerve.
Previous studies showed promise but lacked blinding, involved low numbers of
subjects, or did not use ultrasound localisation of the injection site. The
latter is becoming common practice. In this randomised placebo controlled trial
the FICB with ultrasound localisation of injection of levobupivacaïne will be
compared to the FICB with placebo. It aims to prove that less morphine is used
in the intervention group. Other research parameters are pain scores, length of
hospital stay and minor adverse events related to morphine use. Major adverse
events will be reported separately.

The main study endpoint will be the mean preoperative morphine use per hour in
patients with and without FICB with levobupivacaine, guided by ultrasound.
Secondary parameters will include the pain scores reported by the numerical
rating scale both at rest and during transport to another bed, and minor
adverse events are compared.

The study is designed as a double-blinded randomized placebo-controlled trial.
Study medication will be prepared and blinded by the hospital pharmacy.

Ultrasound guided FICB will be performed after radiological diagnosis. Two
groups will be assigned randomly to injection of weight based volume and dosage
of levobupivacaïne or weight based volume of sodium chloride which is used as
placebo. Escape medication will consist of morphine, which will be administered
by intravenous patient controlled analgesia (PCA).

After the diagnosis patients will be informed of the study and will be asked
for written consent. The FICB will be performed as a single injection. All
patients will receive adequate additional pain management. Simultaneous pain,
nausea and delirium assessments will be carried out preoperatively, according
to standard hospital procedures for pain management. No severe adverse events
have been reported on the FICB in previous literature. Nevertheless necessary
preventative measures and safety precautions will be made.