Postoperative Pain, Acute
Conditions
Keywords
Postoperative pain, Non-steroidal anti-inflammatory drugs, Combination of NSAID, Aspirin, Ketorolac, Celecoxib
Brief summary
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.
Detailed description
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.
Interventions
DRUGAspirin
The patients received aspirin in a dose of 100 mg orally daily.
DRUGKetorolac
The patients received ketorolac in a dose of 90 mg mg orally daily.
DRUGCelecoxib
The patients received celecoxib in a dose of 400 mg orally daily.
Sponsors
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
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 80 Years
Healthy volunteers
No
Inclusion criteria
* The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty. * Informed consent.
Exclusion criteria
* Patients who cannot cooperate with the trial. * Pregnant or breast feeding women, * Оpioid addiction, * Contraindication to NSAIDs (allergy to NSAID, history of ulcer and gastrointestinal bleeding, liver failure, renal failure (eGRF \< 60 ml/kg/1,73m2) and chronic kidney disease 2-5, known thrombocytopenia (\<100 mia/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring postoperative pain using the visual analog scale for pain (VAS-P) | 5 days | The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 5 days | Hemoglobin (HGB) level in g/L |
| Hematocrit | 5 days | Hematocrit level in % |
| Erythrocytes | 5 days | Erythrocytes (RBC) number in 1 litter |
| Arachidonic acid-stimulated platelet tests | 5 days | 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). |
| Fibrinogen | 5 days | Fibrinogen level in g/L |
| Partial thromboplastin time | 5 days | Partial thromboplastin time (PTT) in seconds |
| Prothrombin time | 5 days | Prothrombin time in % |
| Platelets cells | 5 days | Platelets cells (PLT) number in 1 litter |
Countries
Russia
Outcome results
None listed