Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Outpatient Opioid Use
研究概览
简要总结
Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
详细描述
The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.
排除标准
- •Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
研究组 & 干预措施
Exparel
Liposomal Bupivacaine use as active ingredient in the block
干预措施: Exparel (Drug)
Control
Ropivacaine use as active ingredient in the block
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Outpatient Opioid Use
时间窗: 6 weeks
Opioid usage in the immediate post-operative period after hospital discharge
Hospital Length of Stay
时间窗: Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Inpatient post-operative stay after undergoing TKA procedure
Inpatient Opioid Use
时间窗: 1 week
Opioid usage during their inpatient post-operative hospital stay
Numeric Rating Scale (NRS) Pain Score Improvement
时间窗: 6 weeks
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
WOMAC Score
时间窗: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.
次要结局
- Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively(6 weeks)
- Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively(1 week)
研究者
Chinenye Nwachuku
Principal Investigator
St. Luke's Hospital, Pennsylvania