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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846102
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Zuyderland Medisch Centrum

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.

Condition or disease Intervention/treatment Phase
Humans Anesthetics, Local Morphine Pain Management Analgesia Pain Anesthesia, Local Fascia Emergency Medicine Analgesia, Patient-Controlled Ultrasonography Femoral Fracture Drug: Levobupivacaine Drug: Placebo Drug: Acetaminophen Drug: Morphine Procedure: Fascia Iliaca Compartment Block with Levobupivacaine Procedure: Fascia Iliaca Compartment Block with placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded randomized placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: Paracetamol

Drug: Morphine
Morphine 1 mg/ml solution for infusion.
Other Name: 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: Placebo
Sodium Chloride 0,9% for injection/infusion.
Other Name: Placebo (for levobupivacaïne)

Drug: Acetaminophen
Acetaminophen 500 milligram tablet
Other Name: Paracetamol

Drug: Morphine
Morphine 1 mg/ml solution for infusion.
Other Name: Morphine hydrochloride

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846102


Contacts
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Contact: Rory O'Connor, MD +3188 459 7777 r.oconnor@zuyderland.nl
Contact: Sanne Postma, MD +3188 459 7777 s.postma@zuyderland.nl

Locations
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Netherlands
Zuyderland Medisch Centrum Recruiting
Heerlen, Zuid Limburg, Netherlands, 6419PC
Contact: Rory O'Connor, MD    088 459 7777    r.oconnor@zuyderland.nl   
Contact: Sanne Postma, MD    088 459 7777    s.postma@zuyderland.nl   
Sponsors and Collaborators
Zuyderland Medisch Centrum
Fresenius Kabi
Investigators
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Principal Investigator: Sanne Postma, MD Zuyderland Medical Center
Additional Information:
Publications of Results:

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Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT03846102    
Other Study ID Numbers: NL60104.096.16
2016-004698-42 ( EudraCT Number )
16T215 ( Other Identifier: Medical Ethical Committee Zuyderland )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zuyderland Medisch Centrum:
Fascia Iliaca Compartment Block
Peripheral Nerve Block
Elderly
Hip fracture
Levobupivacaïne
Morphine
Emergency Physician
Emergency department
Ultrasound
Pain score
Numerical Rating scale
Additional relevant MeSH terms:
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Emergencies
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disease Attributes
Pathologic Processes
Leg Injuries
Acetaminophen
Morphine
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anesthetics, Local
Anesthetics