Zynrelef Versus Adductor Canal Block

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis; Arthritis Knee
• Interventions: Drug: ZYNRELEF 400Mg-12Mg Extended-Release Solution; Procedure: Ultrasound-Guided Adductor Canal Block; Drug: Ropivacaine 0.5% Injectable Solution

• Registration Number: NCT07216586
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-10
• Study First Submitted QC: 2025-10-10
• Last Update Submitted: 2025-10-10
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Study Start: 2026-01-01
• Primary Completion: 2028-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zynrelef (HTX-011) with application procedure	ZYNRELEF 400Mg-12Mg Extended-Release Solution	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.
Adductor canal block (ACB)	Ultrasound-Guided Adductor Canal Block	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.
Adductor canal block (ACB)	Ropivacaine 0.5% Injectable Solution	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States