Status:
NOT_YET_RECRUITING
Zynrelef Versus Adductor Canal Block
Lead Sponsor:
University of Miami
Conditions:
Knee Osteoarthritis
Arthritis Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.
Eligibility Criteria
Inclusion
- Patients \> 18 years of age
- Patients undergoing primary, unilateral total knee arthroplasty
- Ability to provide informed consent
Exclusion
- Individuals under the age of 18
- Pregnant women
- Prisoners
- Adults unable to consent
- American Society of Anesthesiologists Physical Status score greater than 3
- Patients taking any of the following medications before surgery:
- Long-acting opioids within 3 days
- Any opioids taken within 24 hours
- Bupivacaine HCL within 5 days
- Chronic opioid use or patients with known or suspected daily use of opioids for seven or more consecutive days within 6 months before their scheduled surgery
- Illicit drug use determined by social history
- Alcohol abuse determined by a CAGE Substance Abuse Screening Tool Score of at least two or greater
- Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF
- Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07216586
Start Date
January 1 2026
End Date
January 1 2028
Last Update
October 14 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33125