Total Knee ArthroplastyPhase 4NCT05188053
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
A Phase 4 study testing HTX-011 and ropivacaine , epinephrine , ketorolac diluted in sodium chloride in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- HTX-011 and ropivacaine , epinephrine , ketorolac diluted in sodium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 18 Apr 2024
- Phase
- Phase 4
- 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
- ASA classification I to III, older than or equal to 18 years old.
- Presenting for primary total knee replacement for degenerative joint disease.
- Patient capable of providing their own informed consent.
Who cannot join
- Vulnerable study populations including prisoners.
- Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
- Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
- Patients unable to provide their own informed consent.
- Pregnancy.
- Patients with documented chronic pain syndromes.
Show all 11Show fewer
- Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
- BMI > 45 kg/m^2.
- Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
- Patients with impaired cognitive function.
- Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial
The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
- Conditions
- Total Knee Arthroplasty
- Being tested
- HTX-011, ropivacaine , epinephrine , ketorolac diluted in sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011Drug
Also called Zynrelef
Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
ropivacaine , epinephrine , ketorolac diluted in sodium chlorideDrug
Also called Mayo Clinic standard arthroplasty block
Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| HTX-011 Treatment Group | Experimental | Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia Receives: Drug: HTX-011 |
| Standard Block Control Group | Active comparator | Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia Receives: Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control at 72 Hours Postoperatively
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm.
Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.
Measured: 72-hours postoperatively after total knee arthroplasty
Secondary outcomes (3)
Pain Control at 48 Hours Postoperatively
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm.
Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours
Measured: 48-hours postoperative total knee arthroplasty
Opioid Consumption 72 Hours Postoperatively
Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Measured: 72-hours postoperative total knee arthroplasty
Opioid Consumption 48 Hours Postoperatively
Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs)
Measured: 48 hours postoperative total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start11 Mar 2022
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
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.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew P Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188053
- Sponsor's protocol ID
- 21-010044
- Status last verified
- Apr 2025
- First submitted
- 27 Dec 2021
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A Single Institution, Single-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05188053
- Acronym / sponsor ID
- 21-010044
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Posted 27 Apr 2025
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 study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTX-011 Treatment Group | Experimental | Drug: HTX-011Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia |
| Standard Block Control Group | Active comparator | Drug: ropivacaine , epinephrine , ketorolac diluted in sodium chlorideSubjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA classification I to III, older than or equal to 18 years old.
- Presenting for primary total knee replacement for degenerative joint disease.
- Patient capable of providing their own informed consent.
Key exclusion criteria (11 listed)
- Vulnerable study populations including prisoners.
- Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
- Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
- Patients unable to provide their own informed consent.
- Pregnancy.
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 |
|---|---|---|
| HTX-011Also: ZynrelefSingle dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution | Drug | HTX-011 Treatment Group |
| ropivacaine , epinephrine , ketorolac diluted in sodium chlorideAlso: Mayo Clinic standard arthroplasty blockSingle dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride | Drug | Standard Block Control Group |
Primary outcome
Pain Control at 72 Hours Postoperatively
Time frame: 72-hours postoperatively after total knee arthroplasty
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours.
3 secondary outcomes
Pain Control at 48 Hours Postoperatively
Time frame: 48-hours postoperative total knee arthroplasty
Opioid Consumption 72 Hours Postoperatively
Time frame: 72-hours postoperative total knee arthroplasty
Opioid Consumption 48 Hours Postoperatively
Time frame: 48 hours postoperative total knee arthroplasty
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew P Abdel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HTX-011 and ropivacaine , epinephrine , ketorolac diluted in sodium chloride in people with Total Knee Arthroplasty, run by Mayo Clinic 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 11 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 27 Apr 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Apr 2025). 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 Control at 72 Hours Postoperatively (time frame: 72-hours postoperatively after total knee arthroplasty). 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 27 Apr 2025.