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

Information source: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Total Knee Arthroplasty

Intervention: Liposome Bupivacaine (Drug); Bupivacaine (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: St. Luke's-Roosevelt Hospital Center

Official(s) and/or principal investigator(s):
Ali Shariat, MD, Principal Investigator, Affiliation: St. Luke's-Roosevelt Hospital Center

Overall contact:
Ali Shariat, MD, Phone: 914-409-5023, Email: alishariatmd@gmail.com


The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Clinical Details

Official title: A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Opiate consumption

Secondary outcome: Post-operative VAS scores


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations and Contacts

Ali Shariat, MD, Phone: 914-409-5023, Email: alishariatmd@gmail.com

St. Luke's-Roosevelt Hospital Center, New York, New York 10025, United States
Additional Information

Starting date: May 2015
Last updated: February 19, 2015

Page last updated: August 23, 2015

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