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The search for new safe and effective methods of pain relief after surgery on large joints is still an urgent problem. The most optimal approach in the treatment of postoperative pain is the use of multimodal analgesia with a different mechanism of action that act on various mechanisms of pain and can include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, anticonvulsants, NMDA antagonists, alpha-2-agonists, and sodium and calcium channel blocking agents, as well as local anesthetics. NSAIDs are the most popular and safe means for pain relief. Therefore, a lot of efforts are aimed at increasing the effectiveness of NSAIDs use. The aim of this study was to evaluate the effectiveness of simultaneously administering two or three NSAIDs, compared to using only one NSAID, for pain relief after surgery on large joints such as hip or knee arthroplasty.
This is 6 days, randomized, double blind, parallel group, single-center study in 105 subjects. The distribution into groups was carried out by sequentially alternating the set into 4 groups celecoxib 400 mg orally daily, aspirin 100 mg and ketorolac 90 mg orally daily, ketorolac 90 mg and celecoxib 400 mg orally daily; aspirin 200 mg, ketorolac 90 mg and celecoxib 400 mg orally daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: celecoxib | Active Comparator | The patients received celecoxib in a dose of 400 mg orally daily. The drug was prescribed from the second day of the operation for 5 days. |
|
| Drug: aspirin with ketorolac | Experimental | The patients received aspirin in a dose of 100 mg and ketorolac 90 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days. |
|
| Drug: ketorolac and celecoxib | Experimental | The patients received ketorolac in a dose of 90 mg and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days. |
|
| Drug: aspirin, ketorolac and celecoxib | Active Comparator | The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | The patients received aspirin in a dose of 100 mg orally daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measuring postoperative pain using the visual analog scale for pain (VAS-P) | The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Arachidonic acid-stimulated platelet tests | Assessed by Multiplate ASPItest, Roche Diagnostics GmbH. The platelet aggregation expressed in arbitrary aggregation units (AU) multiplied by the recorded time in minutes (AU*min). | 5 days |
| Hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir U. Emelianov, MD PhD | Federal Center for Traumatology, Orthopedics and Arthroplasty, Cheboksary, Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Center for Traumatology, Orthopedics and Endoprosthetics | Cheboksary | Chuvashskaya Respublika | 429500 | Russia |
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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 |
|---|---|
| D001241 | Aspirin |
| D020910 | Ketorolac |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Ketorolac | Drug | The patients received ketorolac in a dose of 90 mg mg orally daily. |
|
| Celecoxib | Drug | The patients received celecoxib in a dose of 400 mg orally daily. |
|
Hemoglobin (HGB) level in g/L
| 5 days |
| Hematocrit | Hematocrit level in % | 5 days |
| Erythrocytes | Erythrocytes (RBC) number in 1 litter | 5 days |
| Platelets cells | Platelets cells (PLT) number in 1 litter | 5 days |
| Fibrinogen | Fibrinogen level in g/L | 5 days |
| Partial thromboplastin time | Partial thromboplastin time (PTT) in seconds | 5 days |
| Prothrombin time | Prothrombin time in % | 5 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |