Pain Treatment With Combinations of NSAIDs

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

Status: Completed

Conditions: Postoperative Pain, Acute

Treatments: Drug: Celecoxib; Drug: Aspirin; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05994287

2021-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 4 patient groups

Drug: celecoxib

Active Comparator group

Description:

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.

Treatment:

Drug: Celecoxib

Drug: aspirin with ketorolac

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac

Drug: Aspirin

Drug: ketorolac and celecoxib

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac

Drug: Celecoxib

Drug: aspirin, ketorolac and celecoxib

Active Comparator group

Description:

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.

Treatment:

Drug: Ketorolac

Drug: Aspirin

Drug: Celecoxib