Zynrelef Versus Adductor Canal Block

Phase 4Not Yet RecruitingNCT07216586

University of Miami120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Knee Osteoarthritis Arthritis Knee

Interventions

ZYNRELEF 400Mg-12Mg Extended-Release SolutionDRUG

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 BlockPROCEDURE

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 SolutionDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Mean Milligram Morphine Equivalents (MME)

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)

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

Secondary Outcomes

Visual Analog Scale (VAS) pain scores

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"

Time frame: 4 hours after surgery and 6 weeks

Hospital length of stay measured in hours

Average hospital length of stay measured in hours

Time frame: 7 days

Knee range of motion

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.

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

Central Contacts

Natalia Cruz, MD

CONTACT

305-689-5195 nxc971@miami.edu

Data from ClinicalTrials.gov

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