E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10017322 |
E.1.2 | Term | Fractures |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
To reduce the incidence of delirium after surgical treatment for a proximal femur fracture |
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes are
o Delirium Observation Screening Scale (DOSS)-scores (three times daily),
o pain scores on a Numeric Rating Scale (NRS),
o post-operative opioid consumption,
o post-operative consumption of ondansetron for nausea or pruritus,
o Patient questionnaire with the Quality of Recovery-15 on POD 1 (including subscales),
o Pruritus-severity score on POD 1,
o time of mobilization after surgery,
o occurrence of complications such as infections, cerebrovascular disorders, respiratory insufficiency and myocardial injury,
o mortality,
o discharge facility,
o length of hospital stay.
Tertiary outcome is the serum level of NFL on the second post-operative day. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Scheduled for surgical treatment of a proximal femur fracture
Planned spinal anesthesia. |
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E.4 | Principal exclusion criteria |
Contraindications for spinal anesthesia:
- Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg) or heparine (APTT> 30 sec)
- Aortic Valve Stenosis of AVA < 1.0 cm2
- Lumbar malformations (local inflammation, lumbar osteosynthesis material, meningocele, tethered cord)
- Inability to retrieve cerebrospinal fluid by lumbar puncture.
Contra-indications for intrathecal morphine:
- Chronic opioid or benzodiazepine use (>1 month daily use).
Other:
- Allergies to amide-type local anesthetics
- Patients’ refusal |
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E.5 End points |
E.5.1 | Primary end point(s) |
Delirium during hospital admission |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The duration of hospital admission (within 2 weeks) |
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E.5.2 | Secondary end point(s) |
All during hospital admission |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The duration of hospital admission (within 2 weeks) |
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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 | No |
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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When all the patients are discharged from the hospital |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |