Postoperative Pain, AcuteNCT05994287
Pain Treatment With Combinations of NSAIDs
A study testing Aspirin, Ketorolac and Celecoxib in people with Postoperative Pain, Acute, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Aspirin, Ketorolac and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty.
- Informed consent.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center for Traumatology, Orthopedics and Endoprosthetics
Cheboksary, Chuvashskaya Respublika, 429500
About this study
Official title: Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.
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.
Read the 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
- Keywords
- Postoperative pain, Non-steroidal anti-inflammatory drugs, Combination of NSAID, Aspirin, Ketorolac, Celecoxib
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
The patients received aspirin in a dose of 100 mg orally daily.
KetorolacDrug
The patients received ketorolac in a dose of 90 mg mg orally daily.
CelecoxibDrug
The patients received celecoxib in a dose of 400 mg orally daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Aspirin; Drug: Ketorolac; Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Secondary outcomes (8)
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).
Measured: 5 days
Hemoglobin
Hemoglobin (HGB) level in g/L
Measured: 5 days
Hematocrit
Hematocrit level in %
Measured: 5 days
Erythrocytes
Erythrocytes (RBC) number in 1 litter
Measured: 5 days
Platelets cells
Platelets cells (PLT) number in 1 litter
Measured: 5 days
Fibrinogen
Fibrinogen level in g/L
Measured: 5 days
Partial thromboplastin time
Partial thromboplastin time (PTT) in seconds
Measured: 5 days
Prothrombin time
Prothrombin time in %
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir U. Emelianov, MD PhD, Principal investigator, Federal Center for Traumatology, Orthopedics and Arthroplasty, Cheboksary, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994287
- Sponsor's protocol ID
- 2021-2
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.
- ClinicalTrials.gov ID
- NCT05994287
- Acronym / sponsor ID
- 2021-2
- Conditions
- Postoperative Pain, Acute
- Keywords
- Postoperative pain, Non-steroidal anti-inflammatory drugs, Combination of NSAID, Aspirin, Ketorolac, Celecoxib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and ArthroplastyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Drug: celecoxib | Active comparator | Drug: CelecoxibThe 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 | Experimental | Drug: Aspirin, Drug: KetorolacThe 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 | Experimental | Drug: Ketorolac, Drug: CelecoxibThe 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 | Active comparator | Drug: Aspirin, Drug: Ketorolac, Drug: CelecoxibThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty.
- Informed consent.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinThe patients received aspirin in a dose of 100 mg orally daily. | Drug | Drug: aspirin with ketorolac, Drug: aspirin, ketorolac and celecoxib |
| KetorolacThe patients received ketorolac in a dose of 90 mg mg orally daily. | Drug | Drug: aspirin with ketorolac, Drug: aspirin, ketorolac and celecoxib, Drug: ketorolac and celecoxib |
| CelecoxibThe patients received celecoxib in a dose of 400 mg orally daily. | Drug | Drug: aspirin, ketorolac and celecoxib, Drug: celecoxib, Drug: ketorolac and celecoxib |
Primary outcome
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
Time frame: 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).
8 secondary outcomes
Arachidonic acid-stimulated platelet tests
Time frame: 5 days
Hemoglobin
Time frame: 5 days
Hematocrit
Time frame: 5 days
Erythrocytes
Time frame: 5 days
Platelets cells
Time frame: 5 days
Fibrinogen
Time frame: 5 days
Partial thromboplastin time
Time frame: 5 days
Prothrombin time
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir U. Emelianov, MD PhD principal investigator
Federal Center for Traumatology, Orthopedics and Arthroplasty, Cheboksary, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Ketorolac and Celecoxib in people with Postoperative Pain, Acute, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring postoperative pain using the visual analog scale for pain (VAS-P) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.