E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perioperative management of a group of High Pain Responders in total knee-arthroplasty because of kneeosteoarthritis |
Perioperativ optimering af en gruppe af High Pain Responders med total knæalloplastik på baggrund af slidgigt i knæ. |
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E.1.1.1 | Medical condition in easily understood language |
Management of a group of High Pain Responders in total knee-replacement surgery because of kneeosteoarthritis |
Perioperativ optimering af en gruppe af High Pain Responders med 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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003398 |
E.1.2 | Term | Arthroplasty of knee |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
E.1.2 | System Organ Class | 100000004867 |
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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 |
To investigate the effect of high dose steroids on the amount of patients with VAS >30 in a 5-meter walktest, 24 hours postoperatively efter total kneearthroplasty in a High Pain responder cohort. |
At undersøge effekten af højdosis steroid på andelen af patienter med VAS >30 ved en 5 meter gangtest 24 timer postoperativt efter Total KnæAlloplastik i en High Pain Responders kohorte. |
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E.2.2 | Secondary objectives of the trial |
To investigate the reasons for resumed hospitalization in the days after total knee-arthroplasty. |
At undersøge årsager til fortsat indlæggelse i dagene efter total knæalloplastik. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 40 and 90. - Booked for unilateral knee-arthroplasty. - Is able to take part in the investigation(selfreporting of pain and nausea/vomitting) - Understands Danish or English, or has a translator available. - Chronic opioid-user with >29 mg morfine/day or equivalent other opioids and/or Pain Catastrophizing Scale-score of >20. - Signatured written consent.
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- Alder imellem 40 og 90 år. - Bookes til primær TKA unilateralt, - Kan medvirke til undersøgelsen (selvrapportere smerter/kvalme). - Forstår dansk/engelsk, eller har tolk under indlæggelse. - Fast opioid-bruger svarende til >29 mg morfin/dag eller tilsvarende i morfinækvivalenter og/eller PCS score >20. - Underskrevet skriftligt samtykke. |
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E.4 | Principal exclusion criteria |
- Insulin-dependent diabetes melitus. - Ongoing treatment with systemic glucocorticoids or immunesuppressing treatment(apart from inhaled glucocorticoids). - Pregnancy/Breastfeeding - Allergies for the investigational drug. - A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication. |
- Insulinbehandlet DM - Aktuel behandling m. systemisk glukokortikoid eller immunsupressiv behandling (fraset inhalationssteroid). - Graviditet/amning.* - Allergi overfor undersøgelsesmedicin. - Personer som lider af skizofreni eller bipolær sygdom, samt personer som tager fast antipsykotika. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty. |
Andelen af patienter med VAS >30 ved en 5 meter gangtest 24 timer postoperativt efter total knæalloplastik. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours postoperatively |
24 timer postoperativt |
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E.5.2 | Secondary end point(s) |
- Pain upon rest and in a 5-meter walking test 4, 24 and 48 hours postoperatively, and filling out a 7 day pain-diary. - Acummulated painscore 0-48 hours postoperatively in rest and walking. - Duration of stay in PACU. - Length of stay in hospital. - "Why still in hospital"-registration at 9 hours postoperatively and 2 times daily the next 3 days. - Assesment of Opioid-related sideeffects (OR-SDS). - PONV after kneearthroplasty. - The need for, and amount of rescue analgetics during the perioperative, postoperative and reconvalescense phase until day 7. - The need for, and amount of rescue antiemetics during the perioperative, postoperative and reconvalescense phase until day 7. - The influence on the inflammatory response expressed by C-reactive protein(CRP), analysed preoperatively and 24 og 48 hours after surgery. - Quality of sleep, VAS. - Morbidity and mortality(30 and 90 days).
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- Smerter ved hvile og ved 5-meter gangtest til tiden 4 timer postoperativt, samt efter 24 og 48 timer samt 1 uges smertedagbog. - Kummuleret smertescore 0-48 timer v. hvile og gang. - Indlæggelsesvarighed på PACU - Indlæggelsesvarighed total (Length of stay, LOS). - Why still in hospital? Til tiden 9 timer + 2 x dagligt efterfølgende 3 dage (09.00 og 14.00) - Vurdering af Opioid-relaterede bivirkninger(OR-SDS) - Post-operative Quality of Recovery Scale(PQRS) - PONV efter TKA. - Analgetika behov udover standard under operation, i opvågningsfase, samt på sengeafdeling dag 0-5 og i hjemmet indtil dag 7. - Antiemetika behov udover standard medicinering under hele forløb. - Påvirkning af det inflammatoriske respons udtrykt ved C-reaktivt protein(CRP), målt præoperativt og 24 og 48 timer postoperativt. - Undersøgelse af søvnkvalitet. - Morbiditet og mortalitet (30 og 90 dage).
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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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Kontrolleret imod sig selv, lavere dosis(normal dosis) |
Controlled against itself, Lower dose(normal dose) |
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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 | 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |