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临床试验/NCT03130049
NCT03130049已完成不适用

The Effect of the Popliteal Plexus Block on Postoperative Pain After Reconstruction of the Anterior Cruciate Ligament

University of Aarhus4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年9月27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
15
试验地点
4
主要终点
The effect of the popliteal plexus block (PPB)

研究概览

简要总结

The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.

详细描述

Postoperative pain following ACL reconstruction can be alleviated with an ultrasound-guided femoral triangle block (FTB). However, it is the investigators' observation that 10-20 % of the patients still complain of intense pain localized in the center of the knee.

Cadaver dissection studies have shown that an injection into the distal part of the adductor canal will spread to the popliteal fossa, and one dissection study showed consistent spread to the popliteal plexus.

The study team hypothesized that a PPB will reduce the postoperative pain, when it is used as a supplement to the FTB in patients undergoing ACL reconstruction.

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 ACL reconstruction on one of the two trial sites
  • American Society of Anesthesiologists (ASA) status I-III
  • Informed consent

排除标准

  • Patients unable to cooperate
  • Patients not able to speak Danish or with other communication problems
  • Pregnancy
  • Contraindication towards any medical product used in the study
  • Preoperatively reduced sensation on the medial and lateral part of the lower leg
  • Patients with diabetes requiring medical treatment
  • Preoperative intake of opioids (dosed > once daily)
  • ACL revision

结局指标

主要结局

The effect of the popliteal plexus block (PPB)

时间窗: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB

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

次要结局

  • Onset time for PPB(Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB)
  • The effect of the PPB on cutaneous sensation(Baseline, 30 and 60 minutes after PPB)
  • The effect of the PPB on muscle strength(Baseline, 60 minutes after PPB)
  • Percentage of patients with central knee pain(Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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