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| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | 24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day |
|
| Treatment B | Active Comparator | 24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
|
| Placebo | Placebo Comparator | Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 24 mg intravenous Dexamethasone (6 ml) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative usage of morphine 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 | Time Frame: 0-48 hours postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis on heterogeneity in intervention effect of age | Age (years): > 65 vs. ≤ 65 | Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of sex | Sex: male vs. female |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gildhøj Privathospital | Brøndby | 2605 | Denmark | |||
| Bispebjerg Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Aug 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Isotonic saline |
| Drug |
6 ml of isotonic saline |
|
| Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of ASA group | ASA group classification: I+II vs. III | Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest | VAS (mm): > 30 vs. ≤ 30 | Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active | VAS (mm): > 30 vs. ≤ 30 | Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of type of anesthesia | Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia | Time Frame: 0-48 hours postoperatively |
| Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication | Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID | Time Frame: 0-48 hours postoperatively |
| Copenhagen |
| 2400 |
| Denmark |
| Sjællands Universitetshospital, Køge | Køge | 4600 | Denmark |
| Næstsved Sygehus | Næstved | 4700 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |