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临床试验/NCT03653416
NCT03653416已完成4 期

Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2018年3月1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
99
试验地点
1
主要终点
Narcotic Consumption

研究概览

简要总结

Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

详细描述

There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.

There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiology) class I-IV
  • age 18-75.

排除标准

  • ASA class V
  • morbid obesity
  • patient refusal
  • patients with chronic pain or on pain medication
  • allergy to LA
  • patients receiving any additional regional techniques
  • coagulopathy
  • patients receiving systemic anticoagulation
  • local infection and procedures anticipated to last more than 5 hours.

研究组 & 干预措施

Ipack group

Experimental

20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.

干预措施: Ipack (Device)

Ipack group

Experimental

20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.

干预措施: Bupivacaine (Drug)

Ipack group

Experimental

20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.

干预措施: Peri Articular Infiltration (Procedure)

Pai (peri articular) group

Active Comparator

Patients will receive adductor canal catheter and peri articular infiltration.

干预措施: Peri Articular Infiltration (Procedure)

结局指标

主要结局

Narcotic Consumption

时间窗: 24 hours

Narcotic consumption in the first 24 hours

次要结局

  • Ambulation Distance(Post-op Day 1)
  • Bartels Index(Post-op Day 1)
  • Number of Participants With Pain by Location(24 hours)
  • Visual Analogue Score (VAS) for Pain(at 6, 12, 18, and 24 hours post procedure)
  • Time to First Dose of Narcotic Administration(up to 24 hours)
  • PACU Length of Stay(average 24 hours)

研究者

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

Yan Lai

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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