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临床试验/NCT04048889
NCT04048889Unknown不适用

Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年7月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
66
试验地点
1
主要终点
Total iv morphine consumption (mg)

研究概览

简要总结

The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

详细描述

Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.

The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.

Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.

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, Care Provider, 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 scheduled for total knee athroplasty under general anesthesia

排除标准

  • Kidney disease with GFR < 50 ml/mn
  • Daily opioid consumption > 1 month
  • Allergy to local anesthetics
  • Neurological problems of the lower extremity
  • other contraindications to peripheral nerve blocks

研究组 & 干预措施

Popliteal plexus block and continuous femoral nerve block

Experimental

干预措施: Ropivacaine 0.5% Injectable Solution (Drug)

continuous femoral nerve block

Active Comparator

干预措施: Ropivacaine 0.5% Injectable Solution (Drug)

结局指标

主要结局

Total iv morphine consumption (mg)

时间窗: 12 postoperative hours

次要结局

  • Average and maximum pain scores (Numeric rating scale 0-10)(12, 24 and 48 postoperative hours)
  • Popliteal plexus block duration of action (hours)(up to 48 postoperative hours)
  • Knee pain localization (anterior, internal, posterior, lateral, medial)(2, 12, 24 and 48 postoperative hours)
  • Popliteal plexus block procedure time (minutes)(When performing the popliteal plexus block)
  • Total iv morphine consumption (mg)(24 and 48 postoperative hours)
  • Plantarflexion and dorsiflexion ankle strength (Newtons)(2 and 24 postoperative hours)
  • Sciatic extension of popliteal plexus block(2 and 24 postoperative hours)

研究者

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

Kevin Stebler

Principal Investigator

University Hospital, Geneva

研究点 (1)

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