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Knee replacement pain study stopped early: did the drug help?

NCT ID NCT05644496

Symptom relief Sponsor: Baptist Health South Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a drug called ZYNRELEF can control pain and reduce the need for strong opioid painkillers after knee replacement surgery. It included 29 adults aged 35-70 with knee osteoarthritis. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

29 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients undergoing primary unilateral total knee arthroplasty \[Current Procedural Terminology Code: 27447\] 2. Patients with a diagnosis of primary osteoarthritis \[ICD-10 codes: M17.0, M17.10, M17.11, M17.12\] 3. Varus deformity less than 10 degrees 4. Flexion contracture less than 10 degrees 5. Age 35 - 70 years old 6. BMI \< 40 7. Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure Exclusion Criteria: 1. Inflammatory arthritis 2. Post-traumatic arthritis 3. Valgus deformity 4. Severe varus (\> 10 degrees) 5. Severe flexion contracture (\> 10 degrees) 6. Overnight or longer hospital stay after surgery 7. Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair 8. Creatinine \> 1.2 9. Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease 10. Uncontrolled Diabetes mellitus (Glycated Hemoglobin \> 8.0%) 11. Current liver disease 12. Personal history of depression or anxiety disorder 13. Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE) 14. Narcotic or tramadol use within 2 weeks of the planned procedure 15. Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics 16. Walking aid for anything other than the operative joint 17. Contraindication for use of the study drug (as specified by the manufacturer): * Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components * History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs 18. Patients taking the following medications: * Amitriptyline * Nortriptyline * Gabapentin * Pregabalin * Duloxetine (SNRI) * Des-Venlafaxine (SNRI) * Cyclobenzaprine * Baclofen 19. Pregnant or lactating females 20. Patients unable to provide informed consent 21. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee Post operative pain

Contacts and locations

Locations

  • Doctors Hospital

    Miami, Florida, 33146, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.