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Completed

NCT Number: NCT05994287

Pain Treatment With Combinations of NSAIDs

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aspirin

Drug

The patients received aspirin in a dose of 100 mg orally daily.

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.

Primary outcomes

  1. Measuring postoperative pain using the visual analog scale for pain (VAS-P)

    Time frame: 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 outcomes

  1. Arachidonic acid-stimulated platelet tests

    Time frame: 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).

  2. Hemoglobin

    Time frame: 5 days

    Hemoglobin (HGB) level in g/L

  3. Hematocrit

    Time frame: 5 days

    Hematocrit level in %

  4. Erythrocytes

    Time frame: 5 days

    Erythrocytes (RBC) number in 1 litter

  5. Platelets cells

    Time frame: 5 days

    Platelets cells (PLT) number in 1 litter

  6. Fibrinogen

    Time frame: 5 days

    Fibrinogen level in g/L

  7. Partial thromboplastin time

    Time frame: 5 days

    Partial thromboplastin time (PTT) in seconds

  8. Prothrombin time

    Time frame: 5 days

    Prothrombin time in %

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Other

Registry information

Official study title

Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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