Health TrialsbyHealthPanel

Zynrelef Versus Adductor Canal Block

ConditionsKnee OsteoarthritisArthritis Knee
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients > 18 years of age

Patients undergoing primary, unilateral total knee arthroplasty

Ability to provide informed consent

Disqualifiers

Individuals under the age of 18

Pregnant women

Prisoners

Adults unable to consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Zynrelef (HTX-011) with application procedureExperimental treatment 1 intervention
Group B: Adductor canal block (ACB)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

Hospital length of stay measured in hours

Average hospital length of stay measured in hours

Time frame
7 days
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: