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Pain Treatment With Combinations of NSAIDs

Primary Purpose

Postoperative Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Aspirin
Ketorolac
Celecoxib
Sponsored by
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute focused on measuring Postoperative pain, Non-steroidal anti-inflammatory drugs, Combination of NSAID, Aspirin, Ketorolac, Celecoxib

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: Pregnant or breast feeding women, opioid addiction, patients with severe kidney or liver disease

Sites / Locations

  • Federal Center for Traumatology, Orthopedics and Endoprosthetics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Drug: celecoxib

Drug: aspirin with ketorolac

Drug: ketorolac and celecoxib

Drug: aspirin, ketorolac and celecoxib

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2023
Last Updated
August 15, 2023
Sponsor
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
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1. Study Identification

Unique Protocol Identification Number
NCT05994287
Brief Title
Pain Treatment With Combinations of NSAIDs
Official Title
Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
Keywords
Postoperative pain, Non-steroidal anti-inflammatory drugs, Combination of NSAID, Aspirin, Ketorolac, Celecoxib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: celecoxib
Arm Type
Active Comparator
Arm 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.
Arm Title
Drug: aspirin with ketorolac
Arm Type
Experimental
Arm 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.
Arm Title
Drug: ketorolac and celecoxib
Arm Type
Experimental
Arm 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.
Arm Title
Drug: aspirin, ketorolac and celecoxib
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
The patients received aspirin in a dose of 100 mg orally daily.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
The patients received ketorolac in a dose of 90 mg mg orally daily.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
The patients received celecoxib in a dose of 400 mg orally daily.
Primary Outcome Measure Information:
Title
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
Description
The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Arachidonic acid-stimulated platelet tests
Description
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).
Time Frame
5 days
Title
Hemoglobin
Description
Hemoglobin (HGB) level in g/L
Time Frame
5 days
Title
Hematocrit
Description
Hematocrit level in %
Time Frame
5 days
Title
Erythrocytes
Description
Erythrocytes (RBC) number in 1 litter
Time Frame
5 days
Title
Platelets cells
Description
Platelets cells (PLT) number in 1 litter
Time Frame
5 days
Title
Fibrinogen
Description
Fibrinogen level in g/L
Time Frame
5 days
Title
Partial thromboplastin time
Description
Partial thromboplastin time (PTT) in seconds
Time Frame
5 days
Title
Prothrombin time
Description
Prothrombin time in %
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. Exclusion Criteria: Pregnant or breast feeding women, opioid addiction, patients with severe kidney or liver disease
Facility Information:
Facility Name
Federal Center for Traumatology, Orthopedics and Endoprosthetics
City
Cheboksary
State/Province
Chuvashia
ZIP/Postal Code
429500
Country
Russian Federation

12. IPD Sharing Statement

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Pain Treatment With Combinations of NSAIDs

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