Zynrelef Versus Adductor Canal Block

University of Miami

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Arthritis Knee; Knee Osteoarthritis

Treatments: Drug: ZYNRELEF 400Mg-12Mg Extended-Release Solution; Drug: Ropivacaine 0.5% Injectable Solution; Procedure: Ultrasound-Guided Adductor Canal Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07216586

20250529

Details and patient eligibility

About

To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients > 18 years of age
• Patients undergoing primary, unilateral total knee arthroplasty
• Ability to provide informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Zynrelef (HTX-011) with application procedure

Experimental group

Description:

Participants in this group will receive intraoperative analgesia via application of ZYNRELEF (HTX-011) directly into the periarticular tissues at the surgical site following prosthesis implantation and prior to capsule closure. The medication will be applied by the surgeon using sterile technique per manufacturer instructions, targeting the posterior capsule, medial and lateral gutters, and surrounding soft tissues.

Treatment:

Drug: ZYNRELEF 400Mg-12Mg Extended-Release Solution

Adductor canal block (ACB)

Active Comparator group

Description:

Participants in this group will receive a postoperative ultrasound-guided adductor canal block performed by a board-certified anesthesiologist or regional anesthesia-trained provider. The procedure will be conducted under sterile conditions while the patient remains under spinal anesthesia.

Treatment:

Procedure: Ultrasound-Guided Adductor Canal Block

Drug: Ropivacaine 0.5% Injectable Solution