E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain in proximal femur fractures |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
assess the preoperative morphine consumption in ED patients with a proximal femur fracture who received the ultrasound guided FICB with levobupivacaïne |
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E.2.2 | Secondary objectives of the trial |
1. To assess if the ultrasound guide FICB with levobupivacaïne will lead to different average pain scores.
2. To assess if the ultrasound guide FICB with levobupivacaïne will lead to different pain scores during bed to bed transfer.
3. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the occurrence of minor adverse adverse events:
Vomiting
Administration of antiemetics
Delirium
Bradypnea
Desaturation
Sedation
4. To assess the influence of the ultrasound guided FICB with levobupivacaïne on the length of hospital stay.
5. Influence of age on morphine consumption |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patient (>18) diagnosed with a proximal femur fracture upon arrival at the ED. |
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E.4 | Principal exclusion criteria |
No informed consent patient
Skin infection at injection site(s)
Morphine allergy
Levobupivacaine allergy
Operation within an hour after admission
Inability to understand and quantify pain on a NRS
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 femur fracture with other definitive treatment than operation
Transfer to another hospital
Actual morphine use
Distracting pain in other location than hip
Pregnancy
No physician/nurse available for procedure.
BMI > 40
Saturation < 90%
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E.5 End points |
E.5.1 | Primary end point(s) |
Operation
Death
Withdrawal from study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Operation
Death
Withdrawal from study
Discharge from hospital |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |