Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AM-PAC Score to Measure Patients Fitness for Discharge
研究概览
简要总结
Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.
详细描述
This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:
- Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and
- Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis
- •Ages 40- 80 years old
- •American Society of Anesthesiologists class I-III
排除标准
- •Refusal or absolute medical contraindication to peripheral nerve block
- •refusal or absolute medical contraindication to spinal anesthesia
- •conversion of spinal anesthesia to general anesthesia is obtained
- •inability to cooperate
- •allergy to any drug used in this study
- •daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)
- •alcohol dependence or use of any illegal drugs within the last month
- •inability to perform the mobilization test and timed up and go (TUG) test pre-operatively
研究组 & 干预措施
Bupivicaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
干预措施: 0.25% bupivacaine (Drug)
Bupivicaine + Exparel
0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
干预措施: Exparel (Drug)
Bupivicaine + Exparel
0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
干预措施: 0.25% bupivacaine (Drug)
结局指标
主要结局
AM-PAC Score to Measure Patients Fitness for Discharge
时间窗: Post-Operation Day 1
AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
次要结局
- Opioid Consumption During the First 48 Hours After TKA Surgery(During the first 48 hours after surgery)
- Pain Scores During 48 Hrs Postoperatively(48 hours postoperatively)
研究者
Singh Nair
Investigator
Montefiore Medical Center