E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative smerter efter høj tibia osteotomi |
|
E.1.1.1 | Medical condition in easily understood language |
Smerter efter akse-korrigerende operation |
|
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 | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
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 |
At belyse effekten af per- og postoperative bolus infusioner
sammenlignet med femoralisblokade, via behov for supplerende
analgetika og oplevet smerteintensitet efter høj tibia osteotomi. |
|
E.2.2 | Secondary objectives of the trial |
At vurdere gennemoptræningsforløb og stabilitet i høj tibiaosteotomi i forhold til henholdsvis infiltrationsanalgesi og femoralisblokade. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Planlagt primær open-wedge høj tibiaosteotomi
Patienter (mænd/kvinder) 18 år
Patienter der har afgivet skriftlig informeret samtykke og fuldmagt.
Patienter der modtager spinal anæstesi |
|
E.4 | Principal exclusion criteria |
Patienter med intolerance overfor forsøgsmedicinen
Afvisning af el. kontraindiceret spinal anæstesi.
Patienter med rheumatoid arthritis.
Patienter med et Body Mass Indeks (BMI) 35
Patienter der ikke kan læse og forstå dansk. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Forbruget af pn. analgetika postoperativt 12, 24, 48 og 72 timer postoperativt.
Tid til første pn. administration af analgetika postoperativt |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12, 24, 48 og 72 timer postoperativt |
|
E.5.2 | Secondary end point(s) |
Smerteintensitet score ved brug af Visuel Analog Skala (VAS, 0-10 cm) i hvile, ved strakt løftet ben
og ved gang. Smerteintensitets score foretages ½, 1, 2,4 og 6 timer efter hver bolus indgift eksklusiv
om natten. Efter afsluttet aktiv behandling foretages smerteintensitets score kl. 10 og kl. 20 indtil 72
timer postoperativt.
Forekomst af kvalme og opkastninger.
CAS score fra Dag 0 til udskrivelsesdagen
Postoperativ indlæggelsestid.
Smerteintensitets score 3, 6 og 12 uger postoperativt.
Forbrug af smertestillende medicin 3, 6 og 12 uger postoperativt.
Funktionsniveau for knæet ved KOOS scoring.
Stabilitet i osteotomien, målt ved RSA postoperativt, og efter 12 uger
Forekomst af bivirkninger indtruffet fra inklusion til 48 timer postoperativt.
Forekomst af komplikationerne: Transfusions krævende blødninger, hudnekrose DVT, LE,
sårinfektion og dyb infektion fra kirurgisk afslutning indtil 90±10 dage postoperativt. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Kildedata er: lægejournal, anæstesijournal, laboratorierapport, medicin regnskab, patientdagbog,
spørgeskema 3, 6 og 12 uger postoperativt og CRF.
Af spørgeskema fremgår smerteintensitet 3 og 6 uger samt 3 mdr.
Smerteintensitets score 3 og 6 uger samt 3. mdr. postoperativt udfyldes af deltager via et tilsendt
spørgeskema. |
|
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 | Yes |
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 | 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
|
Efter sidste kontrol af sidst opererede patient |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |