MORphine Use in the Fascia Iliaca Compartment Block With UltraSound — MORFICUS  

Pain Clinical Trial

Official title: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound

Status Terminated

Clinical Trial Summary

Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED 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 and minor adverse events related to morphine use.

Clinical Trial Description

Proximal femoral fractures are common in the ED. A major challenge in such subjects is pain management. Suboptimal pain control is associated with stress, a prolonged hospital stay and delirium. Pain or fear of pain can limit early mobilisation, an important goal in treatment. Therefore early pain management is essential. Standard analgesic care consists of acetaminophen, opiates and/or Non-steroidal anti-inflammatory drugs (NSAID's). Opiates can cause respiratory depression, constipation, drowsiness, nausea and vomiting. Especially elderly patients are at risk for these side effects Regional nerve blocks are increasingly being adopted as an alternative pain management to systemic analgesia in the ED. One of such is the Fascia Iliaca Compartment Block (FICB). This is safe and simple to perform. Results from studies, despite lacking ultrasound guidance are promising. No permanent disability resulted from the few minor complications that have been reported. These include bladder perforation, pneumoretroperitoneum and neuropathy of the femoral nerve. Furthermore no additional treatment was necessary. Ultrasound prevents occurrence of such complications.

The studies that have compared this specific block to standard analgesia have shown that regional anaesthesia may be superior. However these studies have low inclusion numbers and lack of randomisation and/or blinding.. Literature up until now has used the numerical rating scale (NRS) as a primary outcome. Although the NRS is a very trustworthy method of measuring pain, the score is a subjective outcome Morphine consumption on the other hand is more objective.

The FICB involves the anatomic space situated at the level of the groin in which important nerves that supply the hip joint lie. Anteriorly the space is covered by the iliac fascia. It is therefore known as the fascia iliaca compartment. By introducing a large volume of local anaesthetic solutions, the femoral, lateral femoral cutaneous and to a lesser extent the obturator nerve are anesthetized. Solutions can spread easily within the compartment. Therefore a safe position injection site can be chosen, minimizing the risk of intravascular injection and nerve damage. The classic position for injection is about 3 centimetres lateral from the femoral nerve. In the original FICB the injection site is determined by using landmarks. The fascia iliaca compartment is then approached by introducing a blunt needle, which enables the physician to feel a 'pop' twice. The first pop is felt when the fascia lata is pierced, the second when the fascia iliaca is passed.

Most ED's nowadays have access to ultrasound. When used for FICB placement, the local anaesthetic solution is visualized as it is introduced into the space. Therefore a higher chance of successful placement of agent and a lower risk of complications can be expected. So far no large double blind randomised placebo controlled trials have evaluated morphine use in ultrasound guided placement of local anaesthetic agents with FICB in the ED. This study is designed as such. Total morphine use will be taken as the primary outcome, administered in the form of patient controlled analgesia (PCA). ;

Related Conditions & MeSH terms

• Analgesia
• Analgesia, Patient-Controlled
• Anesthesia, Local
• Anesthetics, Local
• Emergencies
• Emergency Medicine
• Fascia
• Femoral Fracture
• Femoral Fractures
• Humans
• Morphine
• Pain
• Pain Management
• Ultrasonography

• NCT number: NCT03846102
• Study type: Interventional
• Source: Zuyderland Medisch Centrum
• Status: Terminated
• Phase: Phase 4
• Start date: January 28, 2019
• Completion date: February 18, 2020