Postoperative Pain
Conditions
Brief summary
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Detailed description
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.
Interventions
DRUGDexamethasone
24 mg intravenous Dexamethasone (6 ml)
DRUGIsotonic saline
6 ml of isotonic saline
Sponsors
Copenhagen Trial Unit, Center for Clinical Intervention Research
Naestved Hospital
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
* Participation in the DEX-2-TKA-trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative usage of morphine 0-48 hours postoperatively | Time Frame: 0-48 hours postoperatively | Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis on heterogeneity in intervention effect of sex | Time Frame: 0-48 hours postoperatively | Sex: male vs. female |
| Subgroup analysis on heterogeneity in intervention effect of ASA group | Time Frame: 0-48 hours postoperatively | ASA group classification: I+II vs. III |
| Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest | Time Frame: 0-48 hours postoperatively | VAS (mm): \> 30 vs. ≤ 30 |
| Subgroup analysis on heterogeneity in intervention effect of age | Time Frame: 0-48 hours postoperatively | Age (years): \> 65 vs. ≤ 65 |
| Subgroup analysis on heterogeneity in intervention effect of type of anesthesia | Time Frame: 0-48 hours postoperatively | Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia |
| Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication | Time Frame: 0-48 hours postoperatively | Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID |
| Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active | Time Frame: 0-48 hours postoperatively | VAS (mm): \> 30 vs. ≤ 30 |
Countries
Denmark
Outcome results
None listed