Pain Treatment With Combinations of NSAIDs

NCT ID: NCT05994287

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-01-01

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.

Conditions

Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug: celecoxib

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.

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

The patients received celecoxib in a dose of 400 mg orally daily.

Drug: aspirin with ketorolac

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.

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

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

Ketorolac

Intervention Type: DRUG

The patients received ketorolac in a dose of 90 mg mg orally daily.

Drug: ketorolac and celecoxib

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.

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

The patients received ketorolac in a dose of 90 mg mg orally daily.

Celecoxib

Intervention Type: DRUG

The patients received celecoxib in a dose of 400 mg orally daily.

Drug: aspirin, ketorolac and celecoxib

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.

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

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

Ketorolac

Intervention Type: DRUG

The patients received ketorolac in a dose of 90 mg mg orally daily.

Celecoxib

Intervention Type: DRUG

The patients received celecoxib in a dose of 400 mg orally daily.

Interventions

Aspirin

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

Intervention Type: DRUG

Ketorolac

The patients received ketorolac in a dose of 90 mg mg orally daily.

Intervention Type: DRUG

Celecoxib

The patients received celecoxib in a dose of 400 mg orally daily.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir U. Emelianov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Center for Traumatology, Orthopedics and Arthroplasty, Cheboksary, Russia

Locations

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, Russia

Countries

Russia

Other Identifiers

2021-2

Identifier Type: -

Identifier Source: org_study_id