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Not yet recruiting NCT07216586

Zynrelef Versus Adductor Canal Block

Phase IV Interventional Knee Osteoarthritis Arthritis Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZYNRELEF 400Mg-12Mg Extended-Release Solution, Ultrasound-Guided Adductor Canal Block, Ropivacaine 0.5% Injectable Solution.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Arthritis Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing Opioid Consumption Following Total Knee Arthroplasty With The Perioperative Administration of Zynrelef Versus Adductor Canal Block

Overview

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

Interventions

  • Drug ZYNRELEF 400Mg-12Mg Extended-Release Solution
    A single 14 mL dose of HTX-011 containing 400 mg bupivacaine and 12 mg meloxicam will be applied intraoperatively to the surgical site. This FDA-approved formulation is designed to provide sustained analgesia for up to 72 hours following total knee arthroplasty.
  • Procedure Ultrasound-Guided Adductor Canal Block
    A board-certified anesthesiologist or regional anesthesia-trained provider will perform an ultrasound-guided adductor canal block under sterile conditions while the patient remains under spinal anesthesia. A high-frequency linear ultrasound probe will be used to visualize the adductor canal and saphenous nerve.
  • Drug Ropivacaine 0.5% Injectable Solution
    A single injection of 30 mL of 0.5% ropivacaine will be administered into the adductor canal to provide postoperative analgesia. This dose is standard for adductor canal blocks and is intended to minimize motor blockade while providing effective pain control.

Primary outcome measures

  • Mean Milligram Morphine Equivalents (MME) [Time frame: 12, 16, 20, 24, 48, and 72 hours after surgery]
Secondary outcome measures (3)
  • Visual Analog Scale (VAS) pain scores [Time frame: 4 hours after surgery and 6 weeks]
  • Hospital length of stay measured in hours [Time frame: 7 days]
  • Knee range of motion [Time frame: Within 48 hours of surgery, 6 weeks follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07216586 · 20250529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗