E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Periooperative management of total knee-arthroplasty because of knee-osteoarthritis. |
Perioperativ optimering af total knæalloplastik på baggrund af slidgigt i knæ |
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E.1.1.1 | Medical condition in easily understood language |
Management of total knee-replacement because of knee-osteoarthritis |
Perioperativ optimering af udskiftning af knæ på baggrund af slidgigt i knæ |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023469 |
E.1.2 | Term | Knee arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
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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 |
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after TKA in an HPR population to a standard single high dose systemic preoperative administration in an HPR population. |
At undersøge effekten af en gentaget dosis steroid i forhold til postoperative smerter på en High Pain Respondes (HPR) patient der bliver opereret med total knæalloplastik. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria
• Age > 40
• Primary unilateral TKA
• Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
• Signed written informed consent form
• PCS >20
• Moderate to severe postoperative pain (VAS >30) in a 5-meter walk test in the morning the first day after surgery between 8 am and 12 am (16-26 hours postoperatively).
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Inklusionskriterier
• Alder > 40
• Primær ensidig TKA
• Evne til at deltage i undersøgelsen (forstå skriftligt og talt dansk, selvrapporteret smerte og tilfredshed).
• Underskrevet skriftligt informeret samtykke dokument
• PCS > 20
• Moderat til svær postoperativ smerte (VAS > 30) i en 5 meter gangtest om morgenen den første dag efter operationen mellem kl. 8 og kl. 12 (16-26 timer postoperativt). |
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E.4 | Principal exclusion criteria |
Exclusion criteria
• Ongoing treatment of systemic glucocorticoids or other immunosuppressant treatment apart from inhaled steroids.
• Insulin-dependent diabetes.
• Pregnancy or breastfeeding.*
• Allergies concerning the study-drug.
• Mental disability that could impair a patient’s decision-making capability of giving informed consent and not enabling valid data collection.
• Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
• Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
*Pregnancy: No women with suspected or proven pregnancy is eligible for inclusion.
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Eksklusionskriterier
• Løbende behandling af systemiske glukokortikoid eller anden immunsuppressiv behandling (fraset inhalationssteroid)
• Insulinbehandlet diabetes.
• Graviditet eller amning. *
• Allergier overfor undersøgelses medicin.
• Psykisk handicap, der kan forringe patientens beslutningsproces for at give informeret samtykke og ikke muliggøre gyldig dataindsamling.
• Patienter med kendte diagnoser for skizofreni, vedvarende psykose, bipolar sygdom og / eller en historie med igangværende antipsykotisk behandling.
• Patienter med moduleret smertemodtagelse (erfaring) baseret på andre sygdomme eller skader, f.eks. rygmarvs- eller hjerneskade, svære polyneuropatier eller neurologiske lidelser.
* Graviditet: Ingen kvinder med mistanke om eller bevist graviditet er berettiget til inkludering. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Moderate to severe pain (VAS > 30) upon ambulation in a 5-meter walk test, on the morning of day 2 after TKA surgery.
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Moderat til svær smerte (VAS> 30) ved ambulation i en 5 meter gang test om morgenen på dag 2 efter Total Knæalloplastik operation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
48 hours postoperatively |
48 timer postoperativt |
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E.5.2 | Secondary end point(s) |
• Cumulated pain upon ambulation in a 5-meter walk test day 2-3.
• Cumulated pain score at rest, walking and at night from day 2-7.
• Quality of sleep, pre- and postoperatively from day 0 to day 7.
• Cumulative use of rescue-analgesics per day in hospital day 0 to discharge, and at home from day of discharge to day 7.
• Patient satisfaction with analgesic-regimen at day 7.
• Length of stay (LOS) in hospital, and reasons for prolonged stay (>2 postoperative days).
• Reasons for re-admissions within 30 days.
• Morbidity and mortality (30-day follow-up by Electronic patient journal or telephone).
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- Kumuleret smerte ved i en 5-meters gang testdag 2-3.
• Kumuleret smerte score i hvile, gangtest og om natten fra dag 2-7.
• Søvnkvalitet før og efter operation fra dag 0 til dag 7.
• Kumulativ brug af PN analgetika pr. dag på hospitalets dag 0 til udskrivning og derhjemme fra udskrivningsdagen til dag 7.
• Patienttilfredshed med smertestillende behandling dag 0 til og med dag 7.
• Opholdets længde (Length Of Stay) på hospitalet og årsager til forlænget ophold ( > 2 postoperative dage).
• Årsager til genindlæggelse inden for 30 dage.
• Sygelighed og dødelighed (30 dages opfølgning via elektronisk patientjournal eller telefon). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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.8.2.4 | 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 | 2 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |