E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain after revision surgery after total knee replacement |
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E.1.1.1 | Medical condition in easily understood language |
Pain after revision surgery after total knee replacement |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057129 |
E.1.2 | Term | Revision of total knee arthroplasty |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
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 objective of this trial is to investigate the analgesic effect of dexamethasone (glucocorticoids) after revision-total knee arthroplasty. |
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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 |
• Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s). • Age > 18 • ASA 1- 3. • BMI > 18 and < 45 • Women in the fertile age (i.e. until one year after menopause) must have negative urine HCG pregnancy test • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
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E.4 | Principal exclusion criteria |
• Patients who cannot cooperate with the trial. • Concomitant participation in another trial involving medication • Patients who cannot understand or speak Danish. • Patients with allergy to medicines used in the trial. • Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L) • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administred at the post-anaesthesia unit the first hour postoperatively |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Morphine consumption at 24 hours post surgery |
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E.5.2 | Secondary end point(s) |
Secondary outcomes:
- Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 and 24 hours postoperatively. - Pain scores at rest (VAS) at 6, 24 and hours postoperatively. - Timed up and go test at 24 hours - Number of patients with one or more adverse events in the intervention period (0-24 hours) - Level of nausea at 6 and 24 hours postoperatively. - Level of sedation at 6 and 24 hours postoperatively - Level of dizziness at 6 and 24 hours postoperatively - Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively - Consumption of ondansetron in the period 0-24 hours postoperatively
Exploratory outcomes:
- Quality of sleep the first 24 hours postoperatively - Blood sugar level at 6 and 24 hours - Number of patients with need for antibiotic treatment and/or re-operation within 90 days after surgery. - Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except “prolongation of hospitalisation” - Day’s alive and outside hospital within 90 days after surgery. - Quality of live, function before surgery and at 6 and 12 months after surgery (OKS, EQ-5D-5L and SF-36) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Pain scores, blood sugar level, level of nausea, level of sedation, level of dizziness, number of vomiting: at 6 and 24 hours postoperatively - Number of patients with one or more AE, Timed up and go test, consumption of ondansetron, quality of sleep: at 24 hours postoperatively - Day´s alive outside hospital, Number of patients with one or more SAE's at 90 days post surgery: at 90 days post surgery - OKS, EQ-5D-5L and SF-36 between informed consent and before surgery and at 6 and 12 month after surgery |
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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 | Yes |
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 | 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
| 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
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12 month after the last subject´s surgery |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |