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
Overview
- Phase
- Phase 4
- Intervention
- Liposome Bupivacaine
- Conditions
- Total Knee Arthroplasty
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Locations
- 1
- Primary Endpoint
- Opiate consumption
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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/m
- •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.
Arms & Interventions
Liposome Bupivacaine
Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline
Intervention: Liposome Bupivacaine
Bupivacaine
Single shot femoral nerve block with 20cc of 0.25% bupivacaine
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Opiate consumption
Time Frame: 72 hours
Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine.
Secondary Outcomes
- Post-operative VAS scores(1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs)