Pain Treatment With Combinations of NSAIDs

Sponsor

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty (Other)

Overall Status

Completed

CT.gov ID

NCT05994287

Collaborator

(none)

105

Enrollment

Location

Arms

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain, Acute	Drug: Aspirin Drug: Ketorolac Drug: Celecoxib	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Celecoxib The patients received celecoxib in a dose of 400 mg orally daily.
Experimental: 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.	Drug: Aspirin The patients received aspirin in a dose of 100 mg orally daily. Drug: Ketorolac The patients received ketorolac in a dose of 90 mg mg orally daily.
Experimental: 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.	Drug: Ketorolac The patients received ketorolac in a dose of 90 mg mg orally daily. Drug: Celecoxib The patients received celecoxib in a dose of 400 mg orally daily.
Active Comparator: 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.	Drug: Aspirin The patients received aspirin in a dose of 100 mg orally daily. Drug: Ketorolac The patients received ketorolac in a dose of 90 mg mg orally daily. Drug: Celecoxib The patients received celecoxib in a dose of 400 mg orally daily.

Outcome Measures

Primary Outcome Measures

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

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).
Hemoglobin [5 days]
Hemoglobin (HGB) level in g/L
Hematocrit [5 days]
Hematocrit level in %
Erythrocytes [5 days]
Erythrocytes (RBC) number in 1 litter
Platelets cells [5 days]
Platelets cells (PLT) number in 1 litter
Fibrinogen [5 days]
Fibrinogen level in g/L
Partial thromboplastin time [5 days]
Partial thromboplastin time (PTT) in seconds
Prothrombin time [5 days]
Prothrombin time in %