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临床试验/NCT05971095
NCT05971095招募中不适用

Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty.

Hospital General Universitario de Valencia2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
Quadriceps maximal isometric contraction force differential after the use of a peripheral nerve neuromodulation program with direct current at low frequency combined with high frequency

研究概览

简要总结

The goal of this clinical trial is to compare the maximum isometric contraction force differential of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program in patients undergoing knee arthroplasty. The main questions it aims to answer are if the combination of a peripheral neuromodulation program in the perioperative period improves analgesic quality and short-term functional recovery in patients undergoing knee arthroplasty,

Participants will be asked to reach a maximum knee extension prior to neurostimulation Patients will have the electrodes inserted under direct ultrasound vision and placed near the femoral nerve.

Researchers will compare whether there is a difference in both quadriceps contraction force and analgesia between the stimulated group and the control group.

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
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

  • Over 18 years
  • Those who sign the informed consent
  • Not pregnant
  • Cognitive capacity that allows subjective postoperative evaluations.

排除标准

  • Under 18 years old
  • IC rejection or withdrawal
  • Pregnancy
  • Cognitive impairment
  • Contraindication for Regional Anesthesia

结局指标

主要结局

Quadriceps maximal isometric contraction force differential after the use of a peripheral nerve neuromodulation program with direct current at low frequency combined with high frequency

时间窗: Before neuromodulation, immediately after the first phase of the program, and 24 hours after it.

To compare (analyze) the differential of the maximum isometric contraction force of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program with direct current at low frequency combined with high frequency compared to the usual practice.

次要结局

  • VAS score and Opioid use(In the immediate postoperative period in the PACU and at 24 hours)

研究者

发起方
Hospital General Universitario de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

FERRAN MARQUES PEIRO

Principal Investigator

Hospital General Universitario de Valencia

研究点 (2)

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