MORphine Use in the Fascia Iliaca Compartment Block With UltraSound

NCT03846102 | Terminated Phase 4

• 3 other identifiers: NL60104.096.162016-004698-4216T215
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fascia Iliaca Compartment Block; Peripheral Nerve Block; Elderly; Hip fracture; Levobupivacaïne; Morphine; Emergency Physician; Emergency department; Ultrasound; Pain score; Numerical Rating scale

Outcome Measures

Primary Outcomes (1)

• Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).

  The primary objective is to assess if ultrasound guided FICB with levobupivacaïne results in reduced morphine consumption in ED patients with a proximal femoral fracture at six hours after FICB placement. The morphine consumption will be extracted from the memory from the PCA pump.

  From FICB placement up to 6 hours.

Secondary Outcomes (10)

• Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)

  Time from FICB placement until operation, up to 24 hours. Time point: each hour

• Average of PCA-pump requests for morphine per hour (presses / hour)

  Time from FICB placement until operation, up to 24 hours. Time point: each hour

• Average time to first morphine administration with PCA-pump (minutes)

  Time from FICB placement until operation, up to 24 hours.

• Average pain score at different time points.

  Time from FICB placement until operation, up to 24 hours. Time point: each hour

• Difference in pain scores at movement.

  Time from FICB placement until operation, up to 24 hours. Time point: each hour

Study Arms (2)

Levobupivacaïne

EXPERIMENTAL

Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume) Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml) * \[\<64 kg : 100 mg : 2.0 mg/kg : 40 ml\] * \[65-74 kg : 125 mg : 1.9 mg/kg : 45 ml\] * \[≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml\] Acetaminophen 1 gram (tablets) 4 times daily. Patient Controlled Analgesia Pump with morphine 1 milligram per dose.

Drug: Levobupivacaine; Drug: Acetaminophen; Drug: Morphine; Procedure: Fascia Iliaca Compartment Block with Levobupivacaine

Placebo

PLACEBO COMPARATOR

Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm. Ideal Body Weight : Total volume (ml) * \[\<64 kg : 40 ml\] * \[65-74 kg : 45 ml\] * \[≥ 75 kg : 50 ml\] Acetaminophen 1 gram (tablets) 4 times daily. Patient Controlled Analgesia Pump with morphine 1 milligram per dose.

Drug: Placebo; Drug: Acetaminophen; Drug: Morphine; Procedure: Fascia Iliaca Compartment Block with placebo

Interventions

Levobupivacaine DRUG

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

Also known as: Chirocaïne, Levobupivacaine Hydrochloride

Levobupivacaïne

Placebo DRUG

Sodium Chloride 0,9% for injection/infusion.

Also known as: Placebo (for levobupivacaïne)

Placebo

Acetaminophen DRUG

Acetaminophen 500 milligram tablet

Also known as: Paracetamol

Levobupivacaïne; Placebo

Morphine DRUG

Morphine 1 mg/ml solution for infusion.

Also known as: Morphine hydrochloride

Levobupivacaïne; Placebo

Fascia Iliaca Compartment Block with Levobupivacaine PROCEDURE

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

Also known as: Fascia Iliaca Compartment Block, FIC Block

Levobupivacaïne

Fascia Iliaca Compartment Block with placebo PROCEDURE

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

Also known as: Fascia Iliaca Compartment Block, FIC Block

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with a proximal femoral fracture (femoral neck, trochanteric and sub trochanteric femoral fracture) upon arrival at the ED.

You may not qualify if:

• No informed consent patient
• Skin infection at injection site(s)
• Morphine allergy
• Levobupivacaïne allergy
• Operation within an hour after admission
• Inability to understand and quantify pain on a NRS
• History of dementia
• Neurological deficit of fractured leg upon arrival at the ED
• Trauma with multiple fractures (more than 1)
• Risk of compartment syndrome of ipsilateral lower leg
• Proximal femoral fracture with other definitive treatment than operation
• Transfer to another hospital
• Actual morphine use
• Distracting pain in other location than hip
• Pregnancy

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Fresenius Kabi: collaborator

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Zuid Limburg, 6419PC, Netherlands

Location

Related Publications (27)

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  PMID: 33238043 DERIVED

Related Links

• Guideline anticoagluants and regional anestesia and peripheral nerve blocks of the Dutch Society of Anesthesiology

MeSH Terms

Conditions

Agnosia; Pain; Femoral Fractures; Hip Fractures; Emergencies

Interventions

Levobupivacaine; Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sanne Postma, MD

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Syringes with either placebo or levobupivacaïne will be prepared under aseptic conditions and blinded by the hospital pharmacy. A supply of at least six syringe packs will be kept in the emergency department. Each pack will contain three different doses of either levobupivacain or placebo, of which one will be used according to the weight of the patient. When medication is used, the nurse, physician or researcher will inform the pharmacy, so new medication can be prepared. The hospital pharmacy will keep track of randomisation and register the allocation to either treatment or placebo. Allocation will remain blinded until all patients are included and all data is included.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blinded randomized placebo-controlled trial

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 19, 2019
• Study Start: January 28, 2019
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)