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NCT Number: NCT07216586

Zynrelef Versus Adductor Canal Block

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Arthritis Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33125, United States

Location contact

Colin A. McNamara, MD,MBA

PRINCIPAL_INVESTIGATOR

Michele R. D'Apuzzo, MD

SUB_INVESTIGATOR

Natalia Cruz, MD

CONTACT

[email protected]

305-689-5195

Victor H. Hernandez, MD, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZYNRELEF 400Mg-12Mg Extended-Release Solution

Drug

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.

Other names: HTX-011

ultrasound-guided Adductor Canal Block

Procedure

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.

Ropivacaine 0.5% Injectable Solution

Drug

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 outcomes

  1. Mean Milligram Morphine Equivalents (MME)

    Time frame: 12, 16, 20, 24, 48, and 72 hours after surgery

    Mean cumulative milligram morphine equivalents (MME) administered at 4, 8, 12, 16, 20, 24, 48, and 72 hours following total knee arthroplasty (TKA). Values will be compared between patients receiving Zynrelef and those receiving adductor canal block (ACB)

Secondary outcomes

  1. Visual Analog Scale (VAS) pain scores

    Time frame: 4 hours after surgery and 6 weeks

    Pain scores assessed 4 hours after surgery and at 6 weeks follow up using the Visual Analog Scale (VAS) for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain"

  2. Hospital length of stay measured in hours

    Time frame: 7 days

    Average hospital length of stay measured in hours

  3. Knee range of motion

    Time frame: Within 48 hours of surgery, 6 weeks follow up

    Knee range of motion will be measured in degrees using a standardized goniometer or equivalent clinical tool. Assessments will be conducted postoperatively (within 48 hours of surgery) and at 6-week follow-up. Higher degrees indicate improved joint mobility.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Cruz, MD

CONTACT

[email protected]

305-689-5195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Oct 14, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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