Postoperative pain after total knee arthroplasty MedDRA version: 20.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Dexa-Ratiopharm
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravascular use (N
Sponsors
Naestved Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Scheduled for unilateral, primary TKA, not Oxford (“uni-knee”). • Age = 18 • ASA 1-3 • BMI = 18.0 and = 40.0 • Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 186 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
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 medication used in the trial • Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids. • Patients with at daily use of systemic glucocorticoids • Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids. • Dysregulated diabetes (investigators judgement) • 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 efficacy and safety of one or two doses of dexamethasone after total knee arthroplasty;Secondary Objective: Not applicable;Primary end point(s): Total need for i.v.-equivalent morphine for the first 48 hours postoperatively administered as patient controlled analgesia (PCA) morphine (0-24 hours), on demand oral morphine (24-48 hours) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively after end of surgery (general anaesthesia) or end of spinal anaesthesia. ;Timepoint(s) of evaluation of this end point: i.v.-equivalent morphine for the first 48 hours postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Total need of i.v. morphine the first 24 hours postoperatively • Total need of oral morphine the following 24-48 hours • VAS-pain scores (visual analogue scale (VAS)): o at rest at 6, 24 and 48 hours postoperatively. o with active 45 degrees flexion of the knee (VAS) at 6, 24 and 48 hours postoperatively o highest and average score during the first 24 hours and 24-48 hours • Timed up and go (TUG) test at 24 and 48 hours including maximum pain during the TUG test. • Adverse events o Level of nausea at 6, 24 and 48 hours postoperatively o Level of sedation at 6, 24 and 48 hours postoperatively o Level of dizziness at 6, 24 and 48 hours postoperatively o Number of vomiting episodes (0-48 hours) measured in the periods 0-24 and 24-48 hours postoperatively o Number of patients with one or more patient-reported adverse events in the intervention period • Consumption of ondansetron (and DHB) in the period 0-24 and 24-48 hours postoperatively • Quality of sleep 0-24 and 24-48 hours postoperatively • Level of fatigue at 24 and 48 hours postoperatively • Questionnaire on pain, sleep, satisfaction and use of medication for postoperative days 3-7 • Number of patients with one or more serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines), except “prolongation of hospitalisation” • 90 days follow-up conducted by telephone with qualitative participant reported assessments using EQ5D5L + Oxford-Knee-Score and also need for medical attention and/or intervention including need for anti-biotics and/or re-operation ;Timepoint(s) of evaluation of this end point: See E.5.2 for timepoints in relation to the specific endpoint | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaesthesiology
Naestved Hospital
Outcome results
None listed