Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA

NCT07430085 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025-344
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periarticular Block; Osteoarthritis (OA); Osteoarthritis (OA) of the Knee; Pain After Surgery; Knee Arthroplasty, Total

Keywords

Zynrelef

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Amount of oral Over-the-counter (OTC) pain reliever medications used

  From completion of surgery to 3 days post-operation

• Complications and Adverse Events

  From completion of surgery to 3 days post-op

Study Arms (2)

Zynrelef

EXPERIMENTAL

Periarticular injection of bupivacaine-meloxicam extended release

Combination Product: bupivacaine-meloxicam (extended release)

Control

ACTIVE COMPARATOR

Periarticular injection of bupivacaine, ketorolac, and lidocaine

Drug: Bupivacaine; Drug: Ketorolac; Drug: Lidocaine (drug)

Interventions

bupivacaine-meloxicam (extended release) COMBINATION_PRODUCT

These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia.

Zynrelef

Bupivacaine DRUG

These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

Control

Ketorolac DRUG

These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

Control

Lidocaine (drug) DRUG

These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18-89 years
• Diagnosed with knee osteoarthritis requiring surgical intervention
• Indicated for unilateral RATKA

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Related Publications (5)

• 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.

  BACKGROUND

• Salmons, Harold I. MD, MS1; Amundson, Adam W. MD2; Duncan, Christopher M. MD2; Larson, Dirk R. MS3; Mallinger, Benjamin D. BS1; Couch, Cory G. MD1; Pagnano, Mark W. MD1; Trousdale, Robert T. MD1; Abdel, Matthew P. MD1,a. Bupivacaine-Meloxicam Extended-Release Solution Compared with a Standard Periarticular Injection in Primary Total Knee Arthroplasty: A Randomized Clinical Trial Showing Similar Efficacy in Postoperative Analgesia. The Journal of Bone and Joint Surgery 107(17):p 1918-1925, September 3, 2025. | DOI: 10.2106/JBJS.25.00086

  BACKGROUND

• Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9.

  BACKGROUND

• Dydyk AM, Jain NK, Gupta M. Opioid Use Disorder: Evaluation and Management. [Updated 2024 Jan 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.

  BACKGROUND

• Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Bupivacaine; Ketorolac; Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides

Study Officials

• Andrew Waligora, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Obinna Ajah, MD

CONTACT

877-660-6777; obinna.ajah@ahn.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share