Lead Sponsor

St. Luke's-Roosevelt Hospital Center

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

•1. Male or female, ≥18 years of age
•2. Scheduled to undergo primary unilateral TKA under general anesthesia.
•3. American Society of Anesthesiology (ASA) Physical Status I-III
•4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
•5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

•1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
•2. Planned concurrent surgical procedure (e.g., bilateral TKA).
•3. Body weight \< 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
•4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
•5. Previous participation in a liposome bupivacaine study.
•6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
•7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

Related studies

NCT07020312 · Anterior Cruciate Ligament Reconstruction, Total Hip Arthroplasty (THA), and more

NCT05828810 · Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty

NCT05097976 · Total Knee Arthroplasty

NCT06991231 · Post-Operative Pain, Total Knee Arthroplasty

NCT07069179 · Osteoarthritis, Osteoarthritis (OA) of the Knee, and more

Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty