Pain after revision surgery after total knee replacement MedDRA version: 19.0 Level: LLT Classification code 10057129 Term: Revision of total knee arthroplasty System Organ Class: 100000004865 MedDRA version: 19.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Dexamethason KrKa
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
Sponsors
Næstved Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to investigate the analgesic effect of dexamethasone (glucocorticoids) after revision-total knee arthroplasty.;Secondary Objective: Not applicable;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 ;Timepoint(s) of evaluation of this end point: Morphine consumption at 24 hours post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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);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 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaesthesiology
Næstved Hospital
Outcome results
None listed