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Clinical Trial NCT07430085 for Periarticular Block, Osteoarthritis (OA), Osteoarthritis (OA) of the Knee, Pain After Surgery, Knee Arthroplasty, Total is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA Phase 4 150

Not yet recruiting
Clinical Trial NCT07430085 is designed to study Treatment for Periarticular Block, Osteoarthritis (OA), Osteoarthritis (OA) of the Knee, Pain After Surgery, Knee Arthroplasty, Total. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 31 January 2026 until the study accrues 150 participants. Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), this study is expected to complete by 28 February 2028. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.
Brief 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.
Detailed Description
Opioid use is a well-discussed issue in the United States among orthopedic surgeons, as while these drugs are helpful and necessary, they pose the risk of addiction and ultimately should be used as sparingly as possible. By taking a multimodal approach to pain management, this can be successfully achieved. Periarticular injections are currently used to achieve this goal, and 2021 a bupivacaine-meloxicam extended-rele...Show More
Official Title

Postoperative Pain Outcomes After Use of Bupivacaine-Meloxicam Extended-Release Solution in Robot Assisted Total Knee Arthroplasty: A Prospective Study

Conditions
Periarticular BlockOsteoarthritis (OA)Osteoarthritis (OA) of the KneePain After SurgeryKnee Arthroplasty, Total
Publications
Scientific articles and research papers published about this clinical trial:
  • Joo PY, Chen AF, Richards J, Law TY, Taylor K, Marchand K, Clark G, Collopy D, Marchand RC, Roche M, Mont MA, Malkani AL. Clinical results and patient-reported outcomes following robotic-assisted primary total knee arthroplasty : a multicentre study. Bone Jt Open. 2022 Aug;3(8):589-595. doi: 10.1302/2633-1462.37.BJO-2022-0076.R1.
  • Salmons, Har...
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Other Study IDs
  • 2025-344
NCT ID Number
NCT07430085
Start Date (Actual)
2026-01-31
Last Update Posted
2026-02-27
Completion Date (Estimated)
2028-02-28
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Zynrelef
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalZynrelef
Periarticular injection of bupivacaine-meloxicam extended release
bupivacaine-meloxicam (extended release)
These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia.
Active ComparatorControl
Periarticular injection of bupivacaine, ketorolac, and lidocaine
Bupivacaine
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
Ketorolac
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
Lidocaine (drug)
These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Amount of opioid medications used (measured in morphine milligrams equivalents)
Self-report of opioid medications
From completion of surgery to 3 days post-op
Patient reported outcome measure (Numeric Rating Scale)
Self-report of pain using numeric scale. Title: Numeric Rating Scale; Ranges from 0 to 10, where 10 is maximal pain and 0 is no pain at all.
From completion of surgery to 3 days post-op
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Amount of oral Over-the-counter (OTC) pain reliever medications used
Self-report of Over-the-counter (OTC) pain relievers
From completion of surgery to 3 days post-operation
Complications and Adverse Events
Report of adverse events
From completion of surgery to 3 days post-op
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

Males or females aged 18-89 years

Diagnosed with knee osteoarthritis requiring surgical intervention

Indicated for unilateral RATKA

Pediatric, pregnant, or incarcerated patients

BMI of more than 45 kg/m2

Prolonged opioid use history of >5 mg/day for >1 month

History of contralateral TKA <2 years prior to the index TKA

Type 1 Hypersensitivity to NSAIDs or local anesthetics

Diagnosis of severe renal disease

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) logoAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study Responsible Party
Andrew Waligora, Principal Investigator, Physician, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study Central Contact
Contact: Obinna Ajah, MD, 877-660-6777, [email protected]
No location data.