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To compare postoperative MME consumption 72 hours after TKA in patients receiving intraoperative periarticular HTX-011 (Zynrelef) instillation versus adductor canal block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zynrelef (HTX-011) with application procedure | Experimental | 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) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12, 16, 20, 24, 48, and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 4 hours after surgery and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia Cruz, MD | Contact | 305-689-5195 | nxc971@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colin A. McNamara, MD,MBA | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33125 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000723006 | bupivacaine-meloxicam drug combination |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ultrasound-Guided Adductor Canal Block | 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 | 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. |
|
| Hospital length of stay measured in hours |
Average hospital length of stay measured in hours |
| 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. | Within 48 hours of surgery, 6 weeks follow up |
| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |