跳至主要内容
临床试验/NCT03774966
NCT03774966已完成早期 1 期

Do Patients Who Receive the IPACK and Adductor Canal Catheter Have Better Outcomes Than Patients Receiving the Adductor Canal Catheter Alone for Total Knee Replacements?

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Opioid consumption in milligram morphine equivalents

研究概览

简要总结

This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.

详细描述

Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant post-operative pain. Poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. Regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. The application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. This led to the development of the adductor canal block (ACB) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. Recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (IPACK) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. While the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of practice is the ACB. The investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing total knee replacement without contraindications to regional blocks

排除标准

  • Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder

结局指标

主要结局

Opioid consumption in milligram morphine equivalents

时间窗: 4 days

Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.

次要结局

  • Visual analog pain scores(4 days)
  • Distance ambulated during physical therapy(4 days)

研究者

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

Eva Boyd, MD

Principal Investigator

University of California, Los Angeles

研究点 (2)

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