Clinical trial NCT05994287: Pain Treatment With Combinations of NSAIDs
Official title: Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: Postoperative pain
Non-steroidal anti-inflammatory drugs
Combination of NSAID
Aspirin
Ketorolac
Celecoxib
Lead sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Measuring postoperative pain using the visual analog scale for pain (VAS-P)
timeFrame: 5 days
Secondary outcomes:
measure: Arachidonic acid-stimulated platelet tests
timeFrame: 5 days
measure: Hemoglobin
timeFrame: 5 days
measure: Hematocrit
timeFrame: 5 days
measure: Erythrocytes
timeFrame: 5 days
measure: Platelets cells
timeFrame: 5 days
measure: Fibrinogen
timeFrame: 5 days
measure: Partial thromboplastin time
timeFrame: 5 days
measure: Prothrombin time
timeFrame: 5 days
Other outcomes:
Locations:
city: Cheboksary
country: Russian Federation
facility: Federal Center for Traumatology, Orthopedics and Endoprosthetics
state: Chuvashia
Study officials:
affiliation: Federal Center for Traumatology, Orthopedics and Arthroplasty, Cheboksary, Russia
name: Vladimir U. Emelianov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: