Pain, Postoperative
Conditions
Keywords
Dexamethasone, Arthroplasty, Replacement, Knee, Revision
Brief summary
Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial Trial acronym: DEXRAR Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No gold standard exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy. Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v. Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients. Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.
Interventions
DRUGDexamethasone
A dose of 24 mg dexamethasone given after start of anaesthesia
DRUGSaline isotonic
A dose of 6 ml of isotonic saline given after start of anaesthesia
Sponsors
Daniel Hägi-Pedersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3. * Body mass index (BMI) \> 18 and \< 45 * Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (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.
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. * Patients with daily use of methadone. * 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 | Description |
|---|---|---|
| Morphine consumption the first 24 hours postoperatively | 0-24 hours postoperatively | Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go test | 24 hours postoperatively | Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again |
| Nausea at 24 hours postoperatively (Verbal rating scale) | 24 hours postoperatively | Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
| Vomiting the first 24 hours postoperatively | 0-24 hours postoperatively | Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively |
| Dizziness at 6 hours postoperatively (Verbal rating scale) | 6 hours postoperatively | Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
| Dizziness at 24 hours postoperatively (Verbal rating scale) | 24 hours postoperatively | Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
| Sedation at 6 hours postoperatively (Verbal rating scale) | 6 hours postoperatively | Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
| Sedation at 24 hours postoperatively (Verbal rating scale) | 24 hours postoperatively | Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
| Anti-emetic treatment the first 24 hours postoperatively | 0-24 hours postoperatively | Consumption of ondansetron in the period 0-24 hours postoperatively |
| Pain during movement at 6 hours postoperatively (visual analogue scale) | 6 hours postoperatively | Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100 |
| Pain during movement at 24 hours postoperatively (visual analogue scale) | 24 hours postoperatively | Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100 |
| Pain at rest at 6 hours postoperatively (visual analogue scale) | 6 hours postoperatively | Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100 |
| Pain at rest at 24 hours postoperatively (visual analogue scale) | 24 hours postoperatively | Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100 |
| Adverse events | 0 - 24 hours postoperatively | Number of patients with one or more adverse events in the intervention period (0-24 hours) |
| Nausea at 6 hours postoperatively (Verbal rating scale) | 6 hours postoperatively | Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood sugar level at 24 hours postoperatively | 24 hours postoperatively | Level of blood sugar at 24 hours postoperatively in mmol/L |
| Number of patients with need for antibiotic treatment and/or reoperation within 90 days | 0 - 90 days postoperatively | Number of patients with need for antibiotic treatment and/or reoperation within 90 days after surgery |
| Serious adverse events | 0-90 days postoperatively | Serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to International Conference on Harmonization (ICH) - good clinical practice (GCP) - guidelines) except prolongation of hospitalisation |
| Days alive and outside hospital within 90 days after surgery | 0-90 days postoperatively | Days alive and outside hospital within 90 days after surgery |
| Quality of live, function | Before surgery | Oxford Knee Score (OKS) before surgery |
| Quality of sleep (Verbal rating scale) | 24 hours postoperatively | Level of quality of sleep. Verbal rating scale: very bad, fairly bad, fairly good, very good |
| Blood sugar level at 6 hours postoperatively | 6 hours postoperatively | Level of blood sugar af 6 hours postoperatively in mmol/L |
Countries
Denmark
Outcome results
None listed