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临床试验/NCT01332045
NCT01332045已完成不适用

Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

Henning Lykke Andersen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011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
发起方
入组人数
40
试验地点
2
主要终点
Pain scores

研究概览

简要总结

Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.

The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.

If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • Age: 40-75
  • Unilateral TKA
  • Use of Spinal anesthesia

排除标准

  • Allergy to any of the study medications
  • Intolerance to morphine
  • Contraindication to a spinal anesthetic
  • Intraoperative use of any volatile anesthetic
  • Chronic opioid use
  • ASA Class 4-5
  • Rheumatoid arthritis or Diabetes mellitus with neuropathy
  • Liver or kidney failure
  • BMI above 40
  • Severe COPD

结局指标

主要结局

Pain scores

时间窗: 3 days postoperative

VAS pain scores

次要结局

  • physical therapy progress(3 days postoperative)
  • Opioid consumption(3 days postoperative)

研究者

发起方
Henning Lykke Andersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Henning Lykke Andersen

Consultant

Frederiksberg University Hospital

研究点 (2)

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