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临床试验/NCT03518450
NCT03518450已完成不适用

Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty, a Prospective Comparative Study: Adductor Canal Block vs. Femoral Nerve Block vs. Apex Femoral Triangle Block

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Maximum voluntary isometric contraction (MVIC)

研究概览

简要总结

The objective of this trial is to compare the efficacy of three different nerve blocks as an analgesic option after total knee arthroplasty (TKA), based on muscle strength, mobilization and pain.

The Adductor Canal Block has been proposed as an equally effective technique to the Femoral Nerve Block in terms of pain control after a TKA, with the benefit of preserving muscle function. We hypothesize that a block performed at the apex of the femoral triangle would best balance analgesia with quadriceps function.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of any gender, from 18 to 90 years old that accept to participate in the study.
  • Programmed primary total knee arthroplasty surgery

排除标准

  • Emergent surgery
  • Reinterventions
  • Unstable psychiatric pathology, dementia
  • Kidney or hepatic disease that contraindicates the use of NSAIDs and/or Paracetamol.
  • Allergy to amides local anesthesics, NSAIDs, opioids and/or Paracetamol.
  • Daily use of opioids greater than 30 mg of morphine (or equivalent)
  • Patients under 18 or over 90 years old.
  • Drug abuse
  • Rejection to be a participant of the study.

结局指标

主要结局

Maximum voluntary isometric contraction (MVIC)

时间窗: 6 hours postoperatively

It measures quadriceps strength and is normalized to the body mass index (N \* m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to "reach maximum force and hold for three seconds." Three measurements will be done, and the average will be taken. The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6 hours postoperatively. A higher the percentage will relate with less motor block.

次要结局

  • Quantity of opioids administered(6, 24 and 48 hours postoperatively.)
  • APS-POQ-R.(At 24 hours postoperatively)
  • Pain measurement trough the visual analogue scale (VAS)(6, 24 and 48 hours postoperatively.)
  • Maximum voluntary isometric contraction (MVIC)(24 and 48 hours postoperatively.)
  • Timed Up and Go (TUG)(6, 24 and 48 hours postoperatively.)
  • 30' CST (30 secs Chair Stand Test)(6, 24 and 48 hours postoperatively.)
  • Range of Motion (ROM)(6, 24 and 48 hours postoperatively.)
  • Daniels' Test(6, 24 and 48 hours postoperatively.)
  • 10-PMS (10 point Mobility Scale)(6, 24 and 48 hours postoperatively.)
  • Patient satisfaction(24 and 48 hours postoperatively)
  • Length of hospital stay(at patient discharge, an average of 6 days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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