跳至主要内容
临床试验/NCT02081911
NCT02081911终止不适用

Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing

Hospital for Special Surgery, New York2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
33
试验地点
2
主要终点
Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve

研究概览

简要总结

The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block, 2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume. Quadriceps function will be assessed in the operating room using a skin patch and electrical stimulation. Follow up visits with the patients will continue over the course of 2 days during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing primary unilateral total knee arthroplasty
  • Planned use of combined spinal epidural (CSE) anesthesia
  • Ability to follow study protocol

排除标准

  • Contraindication to a spinal or epidural anesthetic
  • Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
  • Allergy to local anesthetics
  • Pre-existing neuropathy or weakness of the operative limb
  • Any neuromuscular disorder
  • Diabetes type I and II
  • Contraindication to a femoral nerve block or adductor canal nerve block
  • Allergy or intolerance to any of the study medications
  • BMI > 35 kg/m2

结局指标

主要结局

Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve

时间窗: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)

After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.

次要结局

  • Threshold amperage as a percentage of the baseline value(15 minutes after the placement of the peripheral nerve block)
  • Analgesic adequacy(Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op)
  • Ability to complete a straight leg lift(Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (2)

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