E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patienter som får indsat ny knæprotese. Dette kræver smertestillende behandling, ofte med morfin, som har uønskede bivirkninger. Der undersøges effekten af en ny type perifer nerveblokade til behandling af postoperative smerter. Blokaden udføres med et kendt lægemiddel, ropivacain. Der undersøges for effekt af blokaden på ændring i smerte og bivirkningsscore, samt på brug af morfin. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
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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 |
Vores formål er at undersøge effekten af Adductor-Kanal-Blokade som postoperativ smertestillende behandling efter knæalloplastik. Vores hypotese er at Adductor-Kanal-Blokade kan reducere smertescore under 45 graders aktiv flexion af knæet postoperativt sammenlignet med placebo behandling. |
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E.2.2 | Secondary objectives of the trial |
At undersøge om Adductor-Kanal-Blokade kan reducere morfikaforbruget, smertescore i hvile, bivirkninger og fremme mobiliseringen sammenlignet med placebo behandling. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Alder > 40 år og < 85 år · Patienter indstillet til total knæalloplastik i generel anæstesi med Propo-fol og Ultiva. · Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud. · ASA 1-3. · BMI > 18 og < 40
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E.4 | Principal exclusion criteria |
· Patienter som ikke kan samarbejde til undersøgelsen. · Patienter som ikke forstår eller taler dansk. · Allergi over for de i undersøgelsen anvendte stoffer. · Alkohol- og/eller medicinmisbrug – efter investigators skøn. · Dagligt forbrug af stærke opioider (morfin, ketogan, oxynorm, metadon, fentanyl).
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E.5 End points |
E.5.1 | Primary end point(s) |
Smertescore i forbindelse med 45 graders aktiv fleksion af knæet (VAS) til tiden 1 time postoperativt. |
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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 | Yes |
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.8.3 |
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 | Information not present in EudraCT |
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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Der planlægges inkluderet i alt 34 evaluerbare patienter på hovedeffektmål. For at kompensere for drop-outs stiles mod inklusion af 40 patienter. Forsøget er slut for hver forsøgsperson 6 timer efter operation. |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |