E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative smerter efter total knæalloplastik |
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E.1.1.1 | Medical condition in easily understood language |
Smerter efter operation hvor dere r foretaget en total udskiftning af knæledet |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Smerteniveau ved gang (5 meter) 24 timer postoperativt. |
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E.2.2 | Secondary objectives of the trial |
Smerteniveau ved gang (5 meter) og i hvile 2, 4, 6, 24, 28, 32, 48 timer samt morgen og aften 2.-6. postoperative dag. Der suppleres med udregning af kumulerede smertescorer (2-48 timer samt 2.-6. dag).
Supplerende analgetika (kumuleret opioidmængde) 0-48 timer og 2.-6. dage efter operation, registrering af eventuelle bivirkninger ved interview 48 timer postoperativt og 7. postoperative dag, vurdering af depressions- og angst-tendens og søvnkvalitet ved hjælp af spørgeskemaer (se under kliniske vurderinger) to dage før operation, 48 timer postoperativt samt 6. postoperative dag, samt Escitalopram-koncentration i venøs blodprøve 48 timer postoperativt. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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Patienter indstillet til primær, elektiv, unilateral, TKA.
· Alder ³ 18 år og £ 80 år (både mænd og kvinder).
· Etniske danskere.
· Point-score på 21 point eller derover på Pain Catastrophising Scale.
· Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået denne.
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E.4 | Principal exclusion criteria |
· Indtagelse af MAO-hæmmere, dopaminagonister, tramadol, triptaner, tryptophan, linezolid og naturlægemidler indeholdende perikon indenfor de sidste 6 måneder.
· Behandlingskrævende angst eller depressionsproblematik, herunder behandling med SSRI og/eller anden psykofarmaka indenfor de sidste 6 måneder.
· Bipolar affektiv sindslidelse i anamnesen.
· Behandling med glucocorticoider indenfor de sidste 6 måneder.
· Behandling med opioider (både stærke og svage) indenfor de sidste 4 uger.
· Alkoholmisbrug og/eller medicinmisbrug – efter investigators skøn.
· Aktuel malign lidelse i anamnesen.
· Kvinder i den fertile alder (mulig graviditet, amning).
· Epilepsi i anamnesen.
· AK-behandling.
· BMI > 40 kg / m2.
· Sygdom påvirkende central eller perifer nervefunktion (og dermed smerteperception) – efter investigators skøn.
· Demens eller anden kognitiv dysfunktion uforenelig med protokol gennemførsel – efter investigators skøn.
· Behandling med systemiske østrogenholdige hormonsubstituerende midler.
· Gastrointestinal blødning i anamnesen.
· Kendt lever- eller nyreinsufficiens.
· Allergi overfor Citalopram.
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E.5 End points |
E.5.1 | Primary end point(s) |
Smerteniveau ved gang (5 meter) |
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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) |
Smerteniveau ved gang (5 meter)
og Supplerende analgetika (kumuleret opioidmængde)
registrering af eventuelle bivirkninger ved interview
vurdering af depressions- og angst-tendens og søvnkvalitet ved hjælp af spørgeskemaer (se under kliniske vurderinger)
samt Escitalopram-koncentration i venøs blodprøve 48 timer postoperativt. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
i hvile 2, 4, 6, 24, 28, 32, 48 timer samt morgen og aften 2.-6. postoperative dag. Der suppleres med udregning af kumulerede smertescorer (2-48 timer samt 2.-6. dag).
0-48 timer og 2.-6. dage efter operation,
to dage før operation, 48 timer postoperativt samt 6. postoperative dag,
venøs blodprøve 48 timer |
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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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |