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临床试验/NCT03198403
NCT03198403已完成4 期

The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty

Regionshospitalet Silkeborg1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年8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
17
试验地点
1
主要终点
The percentage of patients with postoperative pain NRS

研究概览

简要总结

The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

详细描述

Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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 arthroplasty in spinal anesthesia
  • age > or = 18 years
  • American Society of Anesthesiologists (ASA) status I-III
  • Informed consent

排除标准

  • Patients unable to cooperate
  • Patients not able to speak Danish
  • Pregnancy
  • Contraindication towards ana Medical product used in the study
  • Preoperatively reduced sensation on the medial and lateral part of the lower leg
  • Patients with diabetic requiring Medical treatment
  • Preoperative daily intake of opioids

研究组 & 干预措施

Popliteal plexus block

Experimental

Patients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block

干预措施: Bupivacaine-epinephrine (Drug)

结局指标

主要结局

The percentage of patients with postoperative pain NRS

时间窗: 0 - 60 minutes

Evaluated as the percentage of patients with postoperative pain NRS \>3, dropping in pain score to NRS = or \< 3 after the PPB

次要结局

  • Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3(Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg))
  • Turn off time of spinal anesthesia(Time from arrival in PACU and during maximum 6 hours)
  • The effect of the PPB on cutaneous sensation(NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB))
  • The effect of the PPB on muscle strength of the foot(Baseline and 1 hour after PPB)
  • Onset time of PPB(NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB))
  • Correlation between normal cutaneous sensation and developing of pain(From arrival in PACU and during maximum 6 hours)

研究者

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

Charlotte Runge

Consultant anesthetist, Principal investigator

Regionshospitalet Silkeborg

研究点 (1)

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