Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty
| Status: | Withdrawn |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2017 |
| Start Date: | May 2015 |
| End Date: | July 2016 |
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
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.
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.
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.
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