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临床试验/NCT02777749
NCT02777749已完成4 期

Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

Columbia University1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2016年7月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
155
试验地点
1
主要终点
Change in VAS Pain Scores

研究概览

简要总结

The objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. This randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.

详细描述

Over 600,000 total knee arthroplasties (TKAs) are performed each year in the United States, with expectations for greater than 4 million/year by the year 2030. Since the onset of TKAs in the 1960's, there have been developments that have improved both functionality and patient satisfaction. In the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. The widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. In recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. In addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (PAI), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. In theory, PAI has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction.

The purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.

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

性别
All
接受健康志愿者

入选标准

  • Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

排除标准

  • Allergy to bupivicaine or liposomal bupivicaine.

研究组 & 干预措施

Adductor Canal Block

Active Comparator

15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.

Adductor Canal Block (ACB)

干预措施: Bupivacaine (Drug)

Periarticular SB

Active Comparator

50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

干预措施: Bupivacaine (Drug)

ACB + SB

Active Comparator

15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.

50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Change in VAS Pain Scores

时间窗: Day 0 through Day 3

Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain"

次要结局

  • Range of Knee Flexion(Postoperative day 21)
  • Length of Hospital Stay(Up to Day 5)
  • Change in Activity Level(Day 0 and Day 1)
  • Opioid Consumption(Day 0 through Day 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Geller

Associate Professor of Orthopedic Surgery at the Columbia University Medical Center

Columbia University

研究点 (1)

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