Prospective, Randomized, Double-Blinded, Allocation Concealed Study Comparing the Efficacy of Liposomal Bupivacaine Over Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Achievement of rehabilitative goals
研究概览
简要总结
The purpose of this study is to compare the efficacy and duration of pain relief after total knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to discharge readiness.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of American Society of Anesthesiologist (ASA) I-III physical class with a pre-operative diagnosis of primary osteoarthritis scheduled for elective primary total knee arthroplasty.
- •Patients must be living independently at home prior to undergoing primary total knee arthroplasty with intention of discharge directly to home after hospitalization
排除标准
- •Subjects will not be eligible for this trial if they have a history of allergy to a local anesthetic
- •Known peripheral neuropathy
- •Known connective tissue or immunological disorders
- •Stroke or other known central nervous system disorders
- •Renal dysfunction
- •Hepatic dysfunction
- •Cardiac dysfunction other than hypertension
- •Pregnant subjects
- •Immunosuppression
- •Human immunodeficiency virus (HIV)
- •Alcohol or drug abuse
- •Chronic pain or opioid dependence
- •Coagulopathy or those unable to comply with study requirements.
研究组 & 干预措施
Liposomal bupivacaine
Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.
干预措施: Liposomal bupivacaine (Drug)
Standard bupivacaine plus dexamethasone
Bupivacaine 0.5% 10 mL plus 2 mg dexamethasone for quadriceps sparing femoral nerve block and bupivacaine 0.25% 20 mL plus 2 mg of dexamethasone for posterior knee compartment periarticular injection.
干预措施: Bupivacaine plus dexamethasone (Drug)
结局指标
主要结局
Achievement of rehabilitative goals
时间窗: Time until discharge (up to 2 weeks)
Assessment of temporal achievement of rehabilitative goals for discharge (independent ambulation to 100 feet, stair climbing, timed-up-and-go, independent toileting, ability to get dressed independently, capacity to get in and out of bed, capability to sit and rise from a chair/toilet, independence in personal care, mobilization with walker/crutches, and NRS\<5 on activity).
次要结局
- Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)(Throughout admission (up to 2 weeks))
研究者
Eric Silverman
Director of Regional Anesthesia and Acute Pain Management
Albany Medical College