Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty
Withdrawn before enrolling · Phase 4
Conditions studied: Total Knee Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT01977339
- Run by
- St. Luke's-Roosevelt Hospital Center
- People needed
- 0
- Starts
- 2015-05-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, ≥18 years of age
- Scheduled to undergo primary unilateral TKA under general anesthesia.
- American Society of Anesthesiology (ASA) Physical Status I-III
- Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
You may not qualify if…
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
- Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
- Previous participation in a liposome bupivacaine study.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
Where it is running
- St. Luke's-Roosevelt Hospital Center — New York, New York, United States
Full record on ClinicalTrials.gov
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