Zynrelef Versus Adductor Canal Block

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07216586
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zynrelef (HTX-011) with application procedure
    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.
  • Active Comparator: Adductor canal block (ACB)
    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.

Primary Outcome Measure

Mean Milligram Morphine Equivalents (MME) [ Time Frame: 12, 16, 20, 24, 48, and 72 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33125
Natalia Cruz, MD
[email protected]
305-689-5195
Colin A. McNamara, MD,MBA (PRINCIPAL_INVESTIGATOR)
Victor H. Hernandez, MD, MSc (SUB_INVESTIGATOR)
Michele R. D'Apuzzo, MD (SUB_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
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By specialty
OrthopedicsMusculoskeletal disorders
By research site
University of Miami· Miami, FL

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