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 hver der er 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 | 14.1 |
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 |
Sedationsniveau 6 timer postoperativt.
Smerteniveau ved gang (5 meter) 4, 6, 28, 32, 48 timer postoperativt samt morgen og aften 2.-6. postoperative dag.
Der suppleres med udregning af kumulerede smertescorer (4-48 timer |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patienter indstillet til primær, elektiv, unilateral, TKA.
• Alder 50-85 år, både mænd og kvinder.
• Etniske danskere.
• 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 gabapentinoider, glucocorticoider, opioider (både stærke og svage), anxiolytika, antiepileptika eller antidepresiva indenfor de sidste 4 uger.
• Bipolar affektiv sindslidelse i anamnesen.
• Alkoholmisbrug og/eller medicinmisbrug – efter investigators skøn.
• Aktuel malign lidelse i anamnesen.
• Epilepsi i anamnesen.
• 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.
• Kendt nedsat nyrefunktion.
• Allergi overfor Gabapentinoider.
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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) |
Sedationsniveau .
Smerteniveau ved gang (5 meter)
Smerteniveau i hvile (dels ved patienten liggende fladt i sengen; dels ved passiv fleksion af hofteled 45g og strakt knæled; samt ved passiv fleksion af knæled 60g)
Supplerende analgetika
Uønskede hændelser / bivirkninger
Forbruget af kvalmestillende medicin samt sovemedicin (kumuleret mængde)
Bestemmelse af Gabapentin-koncentrationen i blodprøve
Hospitality and Anxiety Depression Scale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 timer postoperativt
4, 6, 28, 32, 48 timer postoperativt samt morgen og aften 2.-6. postoperative dag.
4, 6, 24, 28, 32, 48 timer postoperativt samt i hvile (ved patienten liggende fladt i sengen) morgen og aften 2.-6. postoperative dag.
0-48 timer postoperativt og 2.-6. dag efter operation.
6, 24, 32, 48 timer postoperativt samt om aftenenen 2.-6. postoperative dag
0-48 timer postoperativt og 2.-6. dag efter operation.
udtages 1. postoperative dag kl. 12. 00, 4 timer efter morgendosis.
udfyldt på 6. dag efter operation |
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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 | No |
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 | 3 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |