Pain Clinical Trial
— MORFICUSOfficial title:
MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Verified date | May 2021 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 55 |
Est. completion date | February 18, 2020 |
Est. primary completion date | February 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland Medisch Centrum | Heerlen | Zuid Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum | Fresenius Kabi |
Netherlands,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / 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 | |
Secondary | Average of PCA-pump requests for morphine per hour (presses / 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 | |
Secondary | Average time to first morphine administration with PCA-pump (minutes) | Average time until patient requests first morphine dose by pressing PCA-pump button. | Time from FICB placement until operation, up to 24 hours. | |
Secondary | Average pain score at different time points. | 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 | |
Secondary | Difference in pain scores at movement. | 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 | |
Secondary | Patients with occurence of NRS > 3. | 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. | |
Secondary | Number of patients with a delirium in preoperative period. | 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. | |
Secondary | The number of patients with morphine related side effects. | 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. | |
Secondary | Number of patients with treatment-related adverse events as assessed by CTCAE v4.0. | 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. | |
Secondary | Time spent on FICB placement in seconds. | The duration of ultrasound guided FICB placement will be measured. | The time from needle entering patient, until procedure is terminated by the emergency physician. |
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