Pain, PostoperativePhase 3NCT05751421
Pain Relief After PrimaryTKA
A Phase 3 study testing Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution, Bupivacaine HCl 0.5% Injectable Solution and primary total knee replacement in people with Pain, Postoperative, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution, Bupivacaine HCl 0.5% Injectable Solution and primary total knee replacement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 28 Feb 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years or older
- Patients undergoing primary unilateral TKA
- Patients receiving spinal anesthesia during primary TKA
- Patients with adequate cognitive function to participate and complete questionnaires for the study
Who cannot join
- Patients undergoing bilateral simultaneous TKA
- Patients undergoing conversion TKA
- Patients undergoing unicompartmental knee arthroplasty
- Patients undergoing patellofemoral arthroplasty
- Patients with an allergy to NSAIDs or bupivacaine
- Patients who have a contraindication to the use of NSAIDs
Show all 10Show fewer
- Patients who are using chronic anticoagulation, precluding them from using NSAIDs
- Patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome
- Patients who are determined to be in severe pain from other concomitant conditions
- Patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
- Conditions
- Pain, Postoperative
- Being tested
- Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution, Bupivacaine HCl 0.5% Injectable Solution, primary total knee replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release SolutionDrug
zynrelef will be administered during surgery
Bupivacaine HCl 0.5% Injectable SolutionDrug
adductor canal block will be performed using bupivacaine before surgery
primary total knee replacementProcedure or surgery
primary total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| primary total knee replacement + Zynrelef | Experimental | Patients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef) Receives: Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution; Procedure: primary total knee replacement |
| primary total knee replacement + adductor canal block (ACB) | Active comparator | Patients undergoing primary total knee replacement with routine adductor canal block Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Procedure: primary total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant
Measured: 14 days
Opioid consumption
Participants will be asked to keep a diary of how much pain medication they took after surgery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start28 Feb 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751421
- Sponsor's protocol ID
- iRIS1128_JLON
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of a Periarticular Instillation of Extended Relief Bupivacaine and Meloxicam With Routine Adductor Canal Blockade for Pain Relief After Primary TKA
- ClinicalTrials.gov ID
- NCT05751421
- Acronym / sponsor ID
- iRIS1128_JLON
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 2 Mar 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.
While a majority of people who undergo TKA have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. Traditionally, opioid medications have been used to control postoperative pain. However, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. In an effort to overcome this, opioid-sparing multimodal analgesia (MMA) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (NSAIDs), acetaminophen, regional nerve blocks, and local anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary total knee replacement + Zynrelef | Experimental | Drug: Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution, Procedure: primary total knee replacementPatients undergoing primary total knee replacement with Extended Relief Bupivacaine and Meloxicam (Zynrelef) |
| primary total knee replacement + adductor canal block (ACB) | Active comparator | Drug: Bupivacaine HCl 0.5% Injectable Solution, Procedure: primary total knee replacementPatients undergoing primary total knee replacement with routine adductor canal block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older
- Patients undergoing primary unilateral TKA
- Patients receiving spinal anesthesia during primary TKA
- Patients with adequate cognitive function to participate and complete questionnaires for the study
Key exclusion criteria (10 listed)
- Patients undergoing bilateral simultaneous TKA
- Patients undergoing conversion TKA
- Patients undergoing unicompartmental knee arthroplasty
- Patients undergoing patellofemoral arthroplasty
- Patients with an allergy to NSAIDs or bupivacaine
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 |
|---|---|---|
| Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solutionzynrelef will be administered during surgery | Drug | primary total knee replacement + Zynrelef |
| Bupivacaine HCl 0.5% Injectable Solutionadductor canal block will be performed using bupivacaine before surgery | Drug | primary total knee replacement + adductor canal block (ACB) |
| primary total knee replacementprimary total knee replacement | Procedure or surgery | primary total knee replacement + Zynrelef, primary total knee replacement + adductor canal block (ACB) |
Primary outcome
Postoperative pain
Time frame: 14 days
This will be measured by a postoperative Visual Analog Score (VAS) completed by the participant
Opioid consumption
Time frame: 14 days
Participants will be asked to keep a diary of how much pain medication they took after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Zynrelef (Bupivacaine 60 MG / Meloxicam 1.8 MG) Per 2.3 ML Extended Release Solution, Bupivacaine HCl 0.5% Injectable Solution and primary total knee replacement in people with Pain, Postoperative, run by Rothman Institute Orthopaedics 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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?
Results are not available in the source record.
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?
Postoperative pain (time frame: 14 days). 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?
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 2 Mar 2023.