Total Knee ReplacementPhase 3NCT05291598
Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)
A Phase 3 study testing IV meloxicam and Ketorolac in people with Total Knee Replacement and Total Hip Replacement, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Total Hip Replacement
- What is being tested?
- IV meloxicam and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18,
- Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
- Patients that have capacity to provide medical consent
Who cannot join
- All patients under the age of 18
- Prisoners, diabetics, increased risk of bleeding, and pregnant women.
- Patients with prior surgery or history of infection on the joint of interest.
- Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
- Patients on dialysis or renal transplant.
- Patients on steroid preoperatively.
Show all 9Show fewer
- Allergy to sulfas
- Inability to provide medical consent.
- Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
- Conditions
- Total Knee Replacement, Total Hip Replacement
- Being tested
- IV meloxicam, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV meloxicamDrug
Participants will be administered meloxicam 30 mg IV push pre-operatively.
KetorolacDrug
Participants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac group | Active comparator | Participants will receive the institution specific joint replacement pain protocol, including ketorolac. Receives: Drug: Ketorolac |
| IV meloxicam group | Experimental | Participants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac. Receives: Drug: IV meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measured by the Numeric Rating Scale
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10.
Measured: 2 hours postoperatively
Pain Measured by the Numeric Rating Scale
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.
Measured: 24 hours postoperatively
Secondary outcomes (8)
Nausea Score as Measured by a Likert Scale
Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting.
Measured: 2 hours postoperatively
Nausea Score as Measured by a Likert Scale
Patients select a score to indicate the severity of their nausea. Scores of 0, 1-2, 3-6, and 7-9 indicate no nausea, mild nausea, moderate nausea, and severe nausea, respectively. The score 10 is assigned to vomiting.
Measured: 24 hours postoperatively
Length of Stay as Measured by Hours in the Hospital
Length of stay for the patient as measured in hours from surgery until the moment of discharge
Measured: Until patient discharged from the hospital
Length of Stay as Measured by Hospital Nights
The total number of overnights spent in the hospital between surgery and discharge
Measured: From surgery until discharge
Length of Stay as Measured by Same Day Discharges
The number of patients which were able to be discharged home the same day as their surgical procedure
Measured: From surgery until discharge
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
The amount of opioids a patient consumes converted into MME for standard comparisons
Measured: Within 2 hours postoperatively
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
The amount of opioids a patient consumes converted into MME for standard comparisons
Measured: Within 24 hours postoperatively
Renal Injury as Measured by the Change in Creatinine Levels
The change in creatinine levels per patient as by comparing their standard preoperative lab creatinine values with the standard postoperative lab creatinine values before discharge from the hospital after their procedure, up to 1 week postoperatively.
Measured: From preoperative baseline labs while hospitalized, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291598
- Sponsor's protocol ID
- 20211214
- Status last verified
- Jul 2024
- First submitted
- 12 Mar 2022
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rizzo MG, Costello JP 2nd, Constantinescu DS, Samineni AV, Moore MR, Shittu AT, Tabibi O, Osman BM, Fiala RS, D'Apuzzo MR, Hernandez VH. Intravenous Meloxicam Versus Ketorolac for Pain Control Following Total Joint Arthroplasty: A Double-Blind Randomized Controlled Trial. J Arthroplasty. 2026 Jul;41(7):1954-1959. doi: 10.1016/j.arth.2025.10.052. Epub 2025 Oct 28.
PubMed 41167538
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05291598
- Acronym / sponsor ID
- 20211214
- Conditions
- Total Knee Replacement, Total Hip Replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac group | Active comparator | Drug: KetorolacParticipants will receive the institution specific joint replacement pain protocol, including ketorolac. |
| IV meloxicam group | Experimental | Drug: IV meloxicamParticipants will receive the institution specific joint replacement pain protocol, however with IV meloxicam substituted for ketorolac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18,
- Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
- Patients that have capacity to provide medical consent
Key exclusion criteria (9 listed)
- All patients under the age of 18
- Prisoners, diabetics, increased risk of bleeding, and pregnant women.
- Patients with prior surgery or history of infection on the joint of interest.
- Patients with an estimated glomerular filtration rate (eGFR) <50 ml/min
- Patients on dialysis or renal transplant.
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 |
|---|---|---|
| IV meloxicamParticipants will be administered meloxicam 30 mg IV push pre-operatively. | Drug | IV meloxicam group |
| KetorolacParticipants will be treated with ketorolac 15 mg IV push intra-operatively, followed by 15 mg IV push every 6 hours scheduled for 2 doses. | Drug | Ketorolac group |
Primary outcome
Pain Measured by the Numeric Rating Scale
Time frame: 2 hours postoperatively
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled from 0-10.
Pain Measured by the Numeric Rating Scale
Time frame: 24 hours postoperatively
A numeric pain rating scale will be used - a higher pain score would indicate higher pain levels. It is scaled 0-10.
8 secondary outcomes
Nausea Score as Measured by a Likert Scale
Time frame: 2 hours postoperatively
Nausea Score as Measured by a Likert Scale
Time frame: 24 hours postoperatively
Length of Stay as Measured by Hours in the Hospital
Time frame: Until patient discharged from the hospital
Length of Stay as Measured by Hospital Nights
Time frame: From surgery until discharge
Length of Stay as Measured by Same Day Discharges
Time frame: From surgery until discharge
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
Time frame: Within 2 hours postoperatively
Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
Time frame: Within 24 hours postoperatively
Renal Injury as Measured by the Change in Creatinine Levels
Time frame: From preoperative baseline labs while hospitalized, up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41167538Rizzo MG, Costello JP 2nd, Constantinescu DS, Samineni AV, Moore MR, Shittu AT, Tabibi O, Osman BM, Fiala RS, D'Apuzzo MR, Hernandez VH. Intravenous Meloxicam Versus Ketorolac for Pain Control Following Total Joint Arthroplasty: A Double-Blind Randomized Controlled Trial. J Arthroplasty. 2026 Jul;41(7):1954-1959. doi: 10.1016/j.arth.2025.10.052. Epub 2025 Oct 28.
- Individual participant dataSharing planned: No
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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.
Victor H Hernandez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV meloxicam and Ketorolac in people with Total Knee Replacement and Total Hip Replacement, run by University of Miami at 1 site in United States.
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 3 inclusion and 9 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 14 Aug 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Measured by the Numeric Rating Scale (time frame: 2 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291598, which also lists 1 linked publication.
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 14 Aug 2024.