Total Shoulder ArthroplastyPhase 4NCT07280195
ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
A Phase 4 study testing Zynrelef and Bupivacaine in people with Total Shoulder Arthroplasty and Pain Management, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Shoulder Arthroplasty, Pain Management
- What is being tested?
- Zynrelef and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Adult patients 18 years or older
- Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)
Who cannot join
- Any persons unable to consent, will not be eligible
- Patients undergoing revision arthroplasty or reverse shoulder arthroplasty
- Proximal humerus fractures
- Inability to have interscalene anesthetic catheter placement
- Compromised baseline renal function (CrCl < 50)
- BMI > 40
Show all 11Show fewer
- History of GI bleed, prior duodenal surgery, or gastric sleeve resection
- Current narcotic use or prior consistent narcotic exposure in the last 6 months
- Use of perioperative oral steroid medications
- Active Workman's compensation claim
- Prior shoulder arthroplasty on the contralateral side in which an interscalene catheter was used
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.
- Conditions
- Total Shoulder Arthroplasty, Pain Management
- Being tested
- Zynrelef, Bupivacaine
- Keywords
- ZYNRELEF, Total shoulder arthroplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZynrelefDrug
ZYNRELEF
BupivacaineDrug
Interscalene block with continuous catheter pump
| Study group | Role | What they receive |
|---|---|---|
| ZYNRELEF | Active comparator | Not described Receives: Drug: Zynrelef |
| Interscalene block with continuous catheter pump | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic consumption
Narcotic consumption measured in morphine equivalent units (MEU)
Measured: From surgery to two-weeks following surgery
Secondary outcomes (2)
Pain management cost
Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump
Measured: Perioperative
Pain management administration
Time needed by the anesthesiologists to perform the blocks in both groups.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start14 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Aleem, Washington University School of Medicine
- Investigators
- Alexander Aleem, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280195
- Sponsor's protocol ID
- 202509174
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07280195
- Acronym / sponsor ID
- 202509174
- Conditions
- Total Shoulder Arthroplasty, Pain Management
- Keywords
- ZYNRELEF, Total shoulder arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Dec 2025 (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 purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZYNRELEF | Active comparator | Drug: Zynrelef |
| Interscalene block with continuous catheter pump | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 18 years or older
- Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)
Key exclusion criteria (11 listed)
- Any persons unable to consent, will not be eligible
- Patients undergoing revision arthroplasty or reverse shoulder arthroplasty
- Proximal humerus fractures
- Inability to have interscalene anesthetic catheter placement
- Compromised baseline renal function (CrCl < 50)
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 |
|---|---|---|
| ZynrelefZYNRELEF | Drug | ZYNRELEF |
| BupivacaineInterscalene block with continuous catheter pump | Drug | Interscalene block with continuous catheter pump |
Primary outcome
Narcotic consumption
Time frame: From surgery to two-weeks following surgery
Narcotic consumption measured in morphine equivalent units (MEU)
2 secondary outcomes
Pain management cost
Time frame: Perioperative
Pain management administration
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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.
Alexander Aleem, MD principal investigator
Washington University School of Medicine
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 Zynrelef and Bupivacaine in people with Total Shoulder Arthroplasty and Pain Management, run by Washington University School of Medicine 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 2 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: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Narcotic consumption (time frame: From surgery to two-weeks following surgery). 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 19 Feb 2026.