Zynrelef Versus Adductor Canal Block

NCT ID: NCT07216586

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

Brief Summary

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

Conditions

Knee Osteoarthritis; Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ZYNRELEF 400Mg-12Mg Extended-Release Solution

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound-Guided Adductor Canal Block

Intervention Type: 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

Intervention Type: 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.

Interventions

ZYNRELEF 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.

Intervention Type: DRUG

Ultrasound-Guided Adductor Canal Block

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.

Intervention Type: PROCEDURE

Ropivacaine 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.

Intervention Type: DRUG

Other Intervention Names

HTX-011

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Colin A. McNamara

Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin A. McNamara, MD,MBA

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Central Contacts

Natalia Cruz, MD

Role: CONTACT

nxc971@miami.edu

305-689-5195

Facility Contacts

Natalia Cruz, MD

Role: primary

nxc971@miami.edu

305-689-5195

Other Identifiers

20250529

Identifier Type: -

Identifier Source: org_study_id