Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
NCT07430085 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-02-27
Summary
Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.
Conditions
- Periarticular Block
- Osteoarthritis (OA)
- Osteoarthritis (OA) of the Knee
- Pain After Surgery
- Knee Arthroplasty, Total
Interventions
- COMBINATION_PRODUCT
-
bupivacaine-meloxicam (extended release)
These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia.
- DRUG
-
Bupivacaine
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
- DRUG
-
Ketorolac
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
- DRUG
-
Lidocaine (drug)
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
Sponsors & Collaborators
-
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
lead OTHER
Principal Investigators
-
Andrew Waligora, MD · Allegheny Health Network
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2028-01-31
- Completion
- 2028-02-28
- FDA Drug
- Yes
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