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
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Opiate consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Liposome Bupivacaine
Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline
干预措施: Liposome Bupivacaine (Drug)
Bupivacaine
Single shot femoral nerve block with 20cc of 0.25% bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Opiate consumption
时间窗: 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.
次要结局
- Post-operative VAS scores(1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs)