Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Pain Intensity at Movement
研究概览
简要总结
Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery
详细描述
This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.
266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.
It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.
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
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Status I-III
- •Scheduled to undergo primary unilateral total knee arthroplasty
排除标准
- •Patients who are pregnant or nursing
- •Alcohol or narcotic dependence within the last 2 years
- •Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
- •BMI > 40kg/m2
- •Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
- •Allergies to amide-type local anesthetics
- •Any disease condition or lab result that could complicate a patients postoperative recovery
- •History of hypotension
- •Abnormal liver, renal or cardiac function
- •Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.
研究组 & 干预措施
Liposome Bupivacaine,
Liposome Bupivacaine 266mg, Knee Infiltration
干预措施: Liposome Bupivacaine (Drug)
Bupivacaine HCl
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Pain Intensity at Movement
时间窗: 24hrs
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.
次要结局
- Opioid Consumption(24hrs)
- Mean Plasma Bupivicaine Level(72hrs)
- Mean Plasma Bupivacaine Levels(48hrs)
- Mean Plasma Bupivacaine Level(Baseline)
- Pain Intensity at Rest(24hrs)
研究者
Joseph Marino M.D.
Physician
Northwell Health