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 perifer blokade type til behandling af postoperative smerter. Blokaden udføres med et kendt lægemiddel, ropivacain. Der undersøges for effekt af blokaden på brug af morfin, samt ændring i smerte og bivirkningsscore. |
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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 smer-testillende behandling efter knæ-alloplastik. Vores hypotese er at Adductor-Kanal-Blokade kan reducere morfikaforbruget 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 smertescore, 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 > 50 år og < 85 år ·Patienter indstillet til primær knæalloplastik i spinal anæstesi med tung bupivakain 0.5%, 2 ml. ·Patienter, som har givet deres skriftlige informerede samtykke til at del-tage i undersøgelsen efter at have forstået protokollens indhold og be-grænsninger 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. ·Patienter der præoperativt ikke kan gennemføre TUG-testen, med eller uden sædvanligt gangredskab (stokke, rollator). ·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) |
·Det totale behov for morfin fra 0 til 24 timer postoperativt, administreret som patientkontrolleret smertebehandling (bolus 2,5 mg, lockout 10 minutter). |
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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 68 evaluerbare patienter på hovedeffektmål. For at kompensere for drop-outs stiles mod inklusion af 70 patienter. Forsøget er slut for hver forsøgsperson 48 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 |