Recruiting

Phase 4

Robot Assisted Total Knee ArthroplastyPost-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT07430085

Conditions

Periarticular Block

Osteoarthritis (OA)

Osteoarthritis (OA) of the Knee

Pain After Surgery

Knee Arthroplasty, Total

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

bupivacaine-meloxicam (extended release)

Bupivacaine

Ketorolac

Lidocaine (drug)

Study Details

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

Study ID

NCT07430085

Start date

Sep 3, 2026

Status verified date

Oct, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Males or females aged 18-89 years

Diagnosed with knee osteoarthritis requiring surgical intervention

Indicated for unilateral RATKA

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zynrelef

Periarticular injection of bupivacaine-meloxicam extended release

active comparator: Control

Periarticular injection of bupivacaine, ketorolac, and lidocaine

Interventions

bupivacaine-meloxicam (extended release)

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

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 measure

Amount of opioid medications used (measured in morphine milligrams equivalents) [ Time Frame: From completion of surgery to 3 days post-op ]
Patient reported outcome measure (Numeric Rating Scale) [ Time Frame: From completion of surgery to 3 days post-op ]

Central Contacts and Locations

Central contacts

Obinna Ajah, MD

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

Locations

AHN Orthopedic Surgery Cranberry Township

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Contacts

Andrew Waligora, MD

877-660-6777 andrew.waligora2@ahn.org

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

Zynrelef

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.