MORphine Use in the Fascia Iliaca Compartment Block With UltraSound

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.

Conditions

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

Interventions

DRUG

Levobupivacaine

Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%

DRUG

Placebo

Sodium Chloride 0,9% for injection/infusion.

DRUG

Acetaminophen

Acetaminophen 500 milligram tablet

DRUG

Morphine

Morphine 1 mg/ml solution for infusion.

PROCEDURE

Fascia Iliaca Compartment Block with Levobupivacaine

Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.

PROCEDURE

Fascia Iliaca Compartment Block with placebo

Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.

Sponsors & Collaborators

• Fresenius Kabi

  collaborator INDUSTRY

• Zuyderland Medisch Centrum

  lead OTHER

Principal Investigators

• Sanne Postma, MD · Zuyderland Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-28

Primary Completion

2020-02-18

Completion

2020-02-18

Countries

• Netherlands

Study Locations