Knee Osteoarthritis, Arthritis Knee
Conditions
Brief summary
To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.
Interventions
DRUGZYNRELEF 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.
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.
DRUGRopivacaine 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Milligram Morphine Equivalents (MME) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) pain scores | 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" |
| Hospital length of stay measured in hours | 7 days | Average hospital length of stay measured in hours |
| Knee range of motion | 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. |
Countries
United States
Contacts
CONTACTNatalia Cruz, MD
PRINCIPAL_INVESTIGATORColin A. McNamara, MD,MBA
University of Miami
Outcome results
None listed