Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This is a randomized prospective study of 60 patients undergoing total knee arthroplasty evaluating the clinical outcomes of liposomal bupivacaine periarticular injections (PAI) when compared to single shot adductor canal block using bupivacaine HCl.
详细描述
Total knee arthroplasty(TKA) is an effective solution for end stage arthritis of the knee; however, post-surgical pain can be difficult to manage and the optimal peri-operative pain management strategy has not been established. This study serves to evaluate the clinical outcomes of liposomal bupivacaine PAI when compared to single shot adductor canal block using bupivacaine HCl in patients undergoing a TKA. The investigators hypothesized that peri-articular injection with liposomal bupivacaine would not be inferior to an adductor canal block using bupivacaine HCl. A total of 60 patients were recruited. Thirty patients were randomized to receive intraoperative liposomal bupivacaine periarticular injection, and another thirty patients randomized to receive a pre-operative adductor canal block using bupivacaine. Both groups otherwise received standard pain management strategies peri-operatively. The primary outcome of interest was post-operative pain, which was measured using the Visual Analog Scale (VAS). Secondary measures included changes in patient function which was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, post-operative ambulation distance, and hospital length of 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing unilateral primary total knee arthroplasty for end stage osteoarthritis or rheumatoid arthritis.
- •All adults > 18 years of age.
排除标准
- •Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.)
- •Adults undergoing bilateral primary total knee arthroplasties.
- •Women who are pregnant.
- •Women who are breastfeeding.
- •Inability to receive successful spinal anesthesia.
- •Allergy to amide anesthetics.
- •Inability to receive IV tranexamic acid.
- •Patients who are unable to speak English.
- •Patients who are less than 66kg.
- •Patients who are opioid dependent. We define opioid dependency as patients who are on a long-acting narcotic or patients who are taking more than six tablets of hydrocodone 5mg or equivalent.
研究组 & 干预措施
Adductor Canal Block Group
Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery.
干预措施: Adductor canal block (Procedure)
Liposomal Bupivacaine Group
Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery.
干预措施: Liposomal Bupivacaine Peri-articular Injection (Procedure)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: VAS pain score on post-operative day #7
Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Outcome measure will be assessed up to 8 weeks)
- Knee range of motion(Outcome measure will be assessed up to 8 weeks)
- Ambulation distance after surgery(Recorded on post-operative day #1)
- Hospital length of stay(Measure outcome will be assess through study completion, on average of 1 year)
研究者
Justin Than
Orthopedic Resident
Good Samaritan Regional Medical Center, Oregon