Arthroplasty, Knee Replacement, Pain, Postoperative
Conditions
Keywords
Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone
Brief summary
The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.
Detailed description
The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone. Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied. Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.
Interventions
DRUGDexamethasone
intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
DRUGSodium Chloride, (24)NaCl 0,9%
intravenous placebo
Sponsors
University of Oulu
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 90 Years
Healthy volunteers
No
Inclusion criteria
* primary total knee replacement surgery * ASA (american society of anesthesiologists) class 1-3
Exclusion criteria
* severe coronary artery disease, heart failure, kidney failure * insulin-dependent DM (diabetes mellitus), poorly controlled type II DM * gastric/duodenal ulcer * allergy/contra-indication for any drug used in the study * corticosteroid use during last 3 months * preoperative use of opioid drugs (excl. codeine, tramadol) * neuropathy/sensory impairment of lower limbs * lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain during walking, NRS 0-10 | at 24 hours postoperatively | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consumption of intravenous oxycodone, milligrams/kilogram body weight | postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours | cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device |
| general wellbeing, NRS 0-10 | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | NRS (numerical rating scale: 0=worst, 10 = best) |
| time to achieve discharge criteria, hours | postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours | time to achieve discharge criteria, hours |
| pain during walking, NRS 0-10 | preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) |
| vomiting, yes/no | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | vomiting, yes/no |
| pain at rest, NRS 0-10 | preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) |
| quality of sleep, NRS 0-10 | postoperatively at 24 hours, at 48 hours | NRS (numerical rating scale: 0=worst, 10 = best) |
| nausea, NRS 0-10 | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea) |
Other
| Measure | Time frame | Description |
|---|---|---|
| wound complication, yes/no | postoperatively up to 90 days | wound complication, yes/no |
| wound infection, yes/no | postoperatively up to 90 days | wound infection, yes/no |
| blood glucose, mmol/l | at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours | blood sample |
| inflammatory reaction, c-reactive protein (CRP) | preoperative, postoperatively: at 24 hours, 48 hours | blood sample |
Countries
Finland
Outcome results
None listed