Pain Treatment With Combinations of NSAIDs

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute
• Interventions: Drug: Celecoxib; Drug: Aspirin; Drug: Ketorolac

• Registration Number: NCT05994287
• Lead Sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-16
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: celecoxib	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.
Drug: aspirin with ketorolac	Aspirin	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: ketorolac and celecoxib	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.
Drug: aspirin with ketorolac	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.
Drug: ketorolac and celecoxib	Ketorolac	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: aspirin, ketorolac and celecoxib	Ketorolac	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, ketorolac and celecoxib	Aspirin	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, ketorolac and celecoxib	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.

Primary Outcome Measures

Name	Time	Method
Measuring postoperative pain using the visual analog scale for pain (VAS-P)	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 Outcome Measures

Name	Time	Method
Prothrombin time	5 days	Prothrombin time in %
Partial thromboplastin time	5 days	Partial thromboplastin time (PTT) in seconds
Hematocrit	5 days	Hematocrit level in %
Erythrocytes	5 days	Erythrocytes (RBC) number in 1 litter
Fibrinogen	5 days	Fibrinogen level in g/L
Arachidonic acid-stimulated platelet tests	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).
Platelets cells	5 days	Platelets cells (PLT) number in 1 litter
Hemoglobin	5 days	Hemoglobin (HGB) level in g/L

Trial Locations

Locations (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics; 🇷🇺 Cheboksary, Chuvashia, Russian Federation