MORphine Use in the Fascia Iliaca Compartment Block With UltraSound (MORFICUS)

May 3, 2021 updated by: Zuyderland Medisch Centrum
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Limburg
      • Heerlen, Zuid Limburg, Netherlands, 6419PC
        • Zuyderland Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. No informed consent patient
  2. Skin infection at injection site(s)
  3. Morphine allergy
  4. Levobupivacaïne allergy
  5. Operation within an hour after admission
  6. Inability to understand and quantify pain on a NRS
  7. History of dementia
  8. Neurological deficit of fractured leg upon arrival at the ED
  9. Trauma with multiple fractures (more than 1)
  10. Risk of compartment syndrome of ipsilateral lower leg
  11. Proximal femoral fracture with other definitive treatment than operation
  12. Transfer to another hospital
  13. Actual morphine use
  14. Distracting pain in other location than hip
  15. Pregnancy
  16. No physician/nurse available for procedure.
  17. BMI > 40
  18. Saturation < 90%
  19. Previously unreported hypotension (systolic blood pressure < 100 mmHg)
  20. ASA IV or higher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Levobupivacaïne

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
Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%
Other Names:
  • Chirocaïne
  • Levobupivacaine Hydrochloride
Drug: Acetaminophen
Acetaminophen 500 milligram tablet
Other Names:
  • Paracetamol
Drug: Morphine
Morphine 1 mg/ml solution for infusion.
Other Names:
  • Morphine hydrochloride
Procedure: Fascia Iliaca Compartment Block with Levobupivacaine
Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.
Other Names:
  • Fascia Iliaca Compartment Block
  • FIC Block
PLACEBO_COMPARATOR: Placebo

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: Acetaminophen
Acetaminophen 500 milligram tablet
Other Names:
  • Paracetamol
Drug: Morphine
Morphine 1 mg/ml solution for infusion.
Other Names:
  • Morphine hydrochloride
Drug: Placebo
Sodium Chloride 0,9% for injection/infusion.
Other Names:
  • Placebo (for levobupivacaïne)
Procedure: Fascia Iliaca Compartment Block with placebo
Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.
Other Names:
  • Fascia Iliaca Compartment Block
  • FIC Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
Time Frame: From FICB placement up to 6 hours.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)
Time Frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
To assess if there is a difference in morphine consumption at different time points in the time until operation. Data will be extracted from PCA pump memory.
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 Frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
The amount of times per hour a patient presses the PCA-pump to receive a bolus of morphine preoperatively.
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 Frame: Time from FICB placement until operation, up to 24 hours.
Average time until patient requests first morphine dose by pressing PCA-pump button.
Time from FICB placement until operation, up to 24 hours.
Average pain score at different time points.
Time Frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Pain scores will be reported with the Numerical Rating Scale (NRS). The NRS is a 11 point scale that is used in the hospital pain protocol. 0 equals to no pain at all, 10 is the worst pain one can imagine. It is regarded as a reliable instrument for pain assessment in patients. Patients will be asked to keep track of their pain score at different time points, starting after FICB placement. They will be asked to report their pain score hourly until 22.00h and from 7.00h the next day. The pain scores will be measured with a dedicated android application, with which patients are asked to self-report their hourly pain scores. When patients are asleep no NRS will be recorded, unless they are awake. Also nurses will report pain scores following their normal rounds when changing shifts. A sleeping patient will be regarded as having a low pain score.
Time from FICB placement until operation, up to 24 hours. Time point: each hour
Difference in pain scores at movement.
Time Frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour

The ED or ward nurse will ask and record the NRS when mobilising patients when necessary. Such situations include for example: bedpan for micturition or stools and bed to bed transfer. The recorded data will include time point, situation and NRS.

Pain scores will be reported with the Numerical Rating Scale (NRS). The NRS is a 11 point scale that is used in the hospital pain protocol. 0 equals to no pain at all, 10 is the worst pain one can imagine.
Time from FICB placement until operation, up to 24 hours. Time point: each hour
Patients with occurence of NRS > 3.
Time Frame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
The number of patient with a NRS > 3, recorded by the patient in the preoperative time.
Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
Number of patients with a delirium in preoperative period.
Time Frame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
The Delirium Observation Screening (DOS) scale is a validated screening tool for detecting delirium in hospitalised patients. In this hospital the DOS scale is routinely screened three times daily by ward nurses. The DOS will also be reported for participating patients in the preoperative period. Subjects with a reported DOS of ≥ 3 are regarded as being at high risk for having a delirium.
Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
The number of patients with morphine related side effects.
Time Frame: This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.

A patient will be regarded of having a side effect of morphine in case of any of the following:

  • Occurrence of nausea
  • Occurrence of vomiting
  • Administration of antiemetic medication
  • Episode of respiratory depression (< 10 breaths/minute)
  • Episode of new hypoxia (SaO2 < 90 % )
  • Administration of naloxone, which will be registered by the nurse on the CRF.
  • Episodes of new hypotension. In this trial hypotension is defined as a systolic blood pressure <90 mmHg, mean arterial pressure <60 mmHg or a drop in systolic blood pressure >40 mmHg.
  • Sedation score > 1. This wil be reported by the nurse with the Pasero Opioïd Induced Sedation Scale, as is prescribed by hospital protocol. S = normal sleep, 1 = drowsy but easy to rouse, 2 = sedated and difficult to rouse, and 3 = unconscious).
This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame: Time from FICB placement until operation, up to 24 hours.
Adverse events relating to the fascia iliaca compartment block or morphine use will be reported.
Time from FICB placement until operation, up to 24 hours.
Time spent on FICB placement in seconds.
Time Frame: The time from needle entering patient, until procedure is terminated by the emergency physician.
The duration of ultrasound guided FICB placement will be measured.
The time from needle entering patient, until procedure is terminated by the emergency physician.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Collaborators

Fresenius Kabi

Investigators

  • Principal Investigator: Sanne Postma, MD, Zuyderland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2019

Primary Completion (ACTUAL)

February 18, 2020

Study Completion (ACTUAL)

February 18, 2020

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (ACTUAL)

February 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL60104.096.16
  • 2016-004698-42 (EUDRACT_NUMBER)
  • 16T215 (OTHER: Medical Ethical Committee Zuyderland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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