Pain Treatment With Combinations of NSAIDs

NCT05994287 | Completed DMC

• 1 other identifier: 2021-2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute

Keywords

Postoperative pain; Non-steroidal anti-inflammatory drugs; Combination of NSAID; Aspirin; Ketorolac; Celecoxib

Outcome Measures

Primary Outcomes (1)

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

  The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).

  5 days

Secondary Outcomes (8)

• Arachidonic acid-stimulated platelet tests

  5 days

• Hemoglobin

  5 days

• Hematocrit

  5 days

• Erythrocytes

  5 days

• Platelets cells

  5 days

Study Arms (4)

Drug: celecoxib

ACTIVE COMPARATOR

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.

Drug: Celecoxib

Drug: aspirin with ketorolac

EXPERIMENTAL

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.

Drug: Aspirin; Drug: Ketorolac

Drug: ketorolac and celecoxib

EXPERIMENTAL

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.

Drug: Ketorolac; Drug: Celecoxib

Drug: aspirin, ketorolac and celecoxib

ACTIVE COMPARATOR

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.

Drug: Aspirin; Drug: Ketorolac; Drug: Celecoxib

Interventions

Aspirin DRUG

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

Drug: aspirin with ketorolac; Drug: aspirin, ketorolac and celecoxib

Ketorolac DRUG

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

Drug: aspirin with ketorolac; Drug: aspirin, ketorolac and celecoxib; Drug: ketorolac and celecoxib

Celecoxib DRUG

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

Drug: aspirin, ketorolac and celecoxib; Drug: celecoxib; Drug: ketorolac and celecoxib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty.
• Informed consent.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty: lead

Study Sites (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Aspirin; Ketorolac; Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Vladimir U. Emelianov, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 25, 2024

Record last verified: 2023-08

Locations

RU (1)