Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 10 Meter Walk Test
研究概览
简要总结
Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.
详细描述
Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is scheduled for elective unilateral TKA;
- •The subject is ≥ 18 years and ≤ 80 years;
- •The subject's weight is between 65-130 kg;
- •The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
- •The patient agrees to receive an adductor canal block;
- •American Society of Anesthesiologists class 1-3.
排除标准
- •Subject is < 18 years of age or >80 years of age;
- •Subject is non-English speaking;
- •Subject is known or believed to be pregnant;
- •Subject is a prisoner;
- •Subject has impaired decision-making capacity per discretion of the Investigator;
- •Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
- •Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
- •Significant pre-existing neuropathy on the operative limb;
- •Significant renal, cardiac or hepatic disease per discretion of the investigator;
- •American Society of Anesthesiologists class 4-5;
- •Known hypersensitivity and/or allergies to local anesthetics;
- •Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
研究组 & 干预措施
Liposomal bupivacaine group
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
干预措施: Peripheral Nerve Blockade (Drug)
Liposomal bupivacaine group
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
干预措施: 10 meter walk test on post-operative day 1 (Behavioral)
Liposomal bupivacaine group
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
干预措施: In person and over the phone questionnaire (Other)
Liposomal bupivacaine group
20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
干预措施: Force transduction of quadriceps strength (Device)
Standard bupivacaine group
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
干预措施: Peripheral Nerve Blockade (Drug)
Standard bupivacaine group
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
干预措施: 10 meter walk test on post-operative day 1 (Behavioral)
Standard bupivacaine group
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
干预措施: In person and over the phone questionnaire (Other)
Standard bupivacaine group
20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
干预措施: Force transduction of quadriceps strength (Device)
结局指标
主要结局
10 Meter Walk Test
时间窗: 24 hours
Time to comfortably walk 10 meters as deemed safe by physical therapy
次要结局
- Pain Scores(Day 0, Day 1, Day 2, Day 3)
- Opioid Consumption in Morphine Equivalents(Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3)
- Number of Participants Who Experienced Nausea(Day 0, Day 1, Day 2, Day 3)
- Quadriceps Strength(24 hours)