跳至主要内容
临床试验/NCT05487053
NCT05487053招募中不适用

The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)

Negovsky Reanimatology Research Institute2 个研究点 分布在 2 个国家目标入组 220 人开始时间: 2024年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
220
试验地点
2
主要终点
Ambulation distance

研究概览

简要总结

Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients.

Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling.

Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle.

The possibility of enhanced recovery after total knee replacement is the reason to compare single-shot adductor canal block and continuous femoral nerve block.

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
Triple (Participant, Investigator, 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

  • Planned primary total knee replacement
  • Planned neuraxial anesthesia
  • Written informed consent

排除标准

  • Urgent surgery
  • Planned revision total knee replacement
  • Known allergic reaction to anesthetics
  • Confirmed localized infection at the puncture sites
  • Confirmed localized tumor at the puncture sites
  • Peripheral neuropathy of the lower extremities
  • Parkinson's disease
  • Previously enrolled in this trial

研究组 & 干预措施

Single-shot adductor canal block

Experimental

干预措施: Single-shot adductor canal block (Procedure)

Continuous femoral nerve block

Active Comparator

干预措施: Continuous femoral nerve block (Procedure)

结局指标

主要结局

Ambulation distance

时间窗: postoperative day 1

Less meters means worse outcome

次要结局

  • Timed up and go test(postoperative day 2)
  • 10 meters walk test(postoperative day 2)
  • length of hospitalization(30 day)
  • 30 seconds chair stand test(postoperative day 2)
  • Ambulation distance(postoperative day 2)
  • 5 times sit to stand test(postoperative day 2)
  • time to readiness to dicharge(30 day)
  • Timed up and go test(postoperative day 1)
  • 10 meters walk test(postoperative day 1)
  • 30 seconds chair stand test(postoperative day 1)
  • 5 times sit to stand test(postoperative day 1)

研究者

发起方
Negovsky Reanimatology Research Institute
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Valery Likhvantsev, MD

Head of the Research V. Negovsky Reanimatology Research Institute

Negovsky Reanimatology Research Institute

研究点 (2)

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