跳至主要内容
临床试验/NCT03121976
NCT03121976已完成不适用

Comparison of Continuous Femoral Nerve Block Using Ultrasound Versus Ultrasound and Nerve Stimulation Using Stimulating Catheter in Patients Undergoing Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2012年1月2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
82
试验地点
2
主要终点
Mean numeric pain score (NRS)

研究概览

简要总结

The purpose of this study is to determine which technique for catheter placement in continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2) nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with pain scores for the first 48 hour post-FNB.

详细描述

Continuous femoral nerve block (cFNB) is a widely used regional anesthetic technique for many lower limb operations, such as total knee arthroplasty (TKA), anterior cruciate ligament repair, tibial osteotomy and patellar surgery. It provides superior pain relief, faster ambulation, shorter hospital stays and less risk of side effects in comparison to patient controlled analgesia (PCA), local anesthetic wound infiltration, or single shot femoral nerve block (FNB).

Stimulating catheters were introduced in 1999 to provide an objective end point to guide continuous nerve block catheter position by maintaining the desired evoked muscle response with nerve stimulation (NS). The main advantages of stimulating catheters are faster onset of sensory and motor block and reduction of local anesthetic drugs consumption. In recent years the precise insertion of continuous catheters has improved especially with the introduction of ultrasound (US)-guided imaging to regional anesthesia practice and advances in scanning techniques. That led to a call to reduce cost by switching to non-stimulating catheters. However, most studies comparing both catheters lacked anesthetic technique standardization and adequate sample size.

In this prospective randomized controlled trial, we compared postoperative analgesic efficacy and opioids consumption in patients having cFNB insertion using US alone and that of US combined with NS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists physical status I to III patients
  • Aged 18-75 scheduled for unilateral TKA

排除标准

  • History of significant psychiatric problems
  • BMI > 40 kg/m^2
  • Prior surgery in the inguinal region
  • Neurological disease with sensory or motor deficit
  • Diabetic neuropathy
  • Contraindication to any study medications
  • Daily opioid consumption >10 mg PO morphine (or equivalent) for 2 weeks prior to surgery

结局指标

主要结局

Mean numeric pain score (NRS)

时间窗: 24 hours post-block insertion

Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10

次要结局

  • Sensation over the skin of the thigh to determine sensory block using 3 point grading scale(30 min post-block insertion)
  • Quadriceps muscle strength to determine motor block using 3 point grading scale(30 min post-block insertion)
  • Time to perform the block(At the time of block procedure)
  • Total hydromorphone used (oral and intravenous PCA)(48 hours post-block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验