Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number Physical Therapy Sessions Necessary for Discharge
研究概览
简要总结
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.
详细描述
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator
排除标准
- •Age <18 years
- •Pregnant or breastfeeding
- •Non-English-speaking
- •Unable to give informed consent
- •Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
- •Patients unable to complete a device-assisted 140 foot walk at baseline
- •Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
- •Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
- •Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)
研究组 & 干预措施
Liposomal Bupivacaine
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
干预措施: Liposomal bupivacaine (Drug)
Standard of Care
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Number Physical Therapy Sessions Necessary for Discharge
时间窗: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.
次要结局
- Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay(Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.)
- Length of Stay (LOS, in Days)(Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.)
- Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)(Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.)
- Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay(Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.)
- Total Cost of Care (Dollars)(Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.)
- Hospital Readmission Not Including Admissions Planned Procedures(Participants will be followed for 30 days after leaving the hospital.)