Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Length of stay (LOS, in days)
研究概览
简要总结
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female between the ages of 18-65
- •Patients willing and able to sign the informed consent
- •Patients able to comply with follow-up requirements including self-evaluations
- •Patients requiring a primary total knee replacement
- •Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
排除标准
- •Revision total knee arthroplasty
- •Bilateral total knee arthroplasty
- •Patients with inflammatory arthritis
- •Patients with a body mass index (BMI) > 40
- •Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
- •Current use of opioid drugs
- •Patients with a history of total or unicompartmental reconstruction of the affected joint
- •Patients that have had a high tibial osteotomy or femoral osteotomy
- •Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
- •Patients with a systemic or metabolic disorder leading to progressive bone deterioration
- •Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
- •Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
- •Patients with knee fusion to the affected joint
- •Patients with an active or suspected latent infection in or about the knee joint
- •Patients that are prisoners
研究组 & 干预措施
Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants
干预措施: liposomal bupivacaine (Drug)
Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants
干预措施: bupivacaine HCl (Drug)
Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants
干预措施: Saline (Drug)
Adductor canal and tibial nerve block
Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour
干预措施: bupivacaine HCl (Drug)
Adductor canal and tibial nerve block
Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Length of stay (LOS, in days)
时间窗: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Time to ambulation (in hours)
时间窗: 2-6 hours
次要结局
- Pain as assessed by visual analog scale (VAS) on postoperative day 3(72 hours)
- Pain as assessed by visual analog scale (VAS) on postoperative day 2(48 hours)
- Pain as assessed by visual analog scale (VAS) on postoperative day 1(24 hours)
- Postoperative complications and adverse events(2 weeks)
- Pain as assessed by visual analog scale (VAS) on postoperative day 4(96 hours)
- Pain as assessed by visual analog scale (VAS) on postoperative day 0(6 hours)
- Pain as assessed by visual analog scale (VAS) on postoperative day 5(120 hours)
- Opioid consumption in oral morphine equivalents (OMEs, in milligrams)(Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.)