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临床试验/NCT02020096
NCT02020096已完成不适用

A Randomized Comparison of Ultrasound Plus Nerve Stimulator Guided Lumbar Plexus Block to Conventional Nerve Stimulator Guided Technique Using Winnie Approach

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Onset time of sensory block to cold and pinprick

研究概览

简要总结

Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Some case series have demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks and axillary brachial plexus blocks under ultrasound than with conventional techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the popliteal fossa compared with single injection, nerve stimulator-guided block using either a tibial or peroneal endpoint. Despite this impressive profile, the application of the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar plexus block is traditionally performed using surface anatomical landmarks and nerve stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its deep anatomic location and the "acoustic shadow" of the overlying transverse processes. Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the lumbar paravertebral region with the ultrasound beam being insonated through the intertransverse space (ITS) and directed medially toward the intervertebral foramen (PMTS-ITS) may overcome the problem of the "acoustic shadow" and allow clear visualization of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus blocks has not been studied extensively and its advantages are not validated in a clinical study. Thus, we designed this prospective, randomized, subject and assessor blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus block combined with nerve stimulation and a conventional technique on time required to readiness for surgery in patients undergo knee arthroscopy surgery.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Age 18-70yr
  • American Society of Anesthesiologists physical status I-II
  • Patients scheduled to undergo knee arthroscopy surgery
  • Ultrasound visibility score equal or great than 10

排除标准

  • Body mass index more than 35 kg/m²
  • Pregnant or lactating women
  • Allergy to local anesthetics
  • Coagulopathy, on anticoagulants
  • Malignancy or infection at puncture site
  • Significant peripheral neuropathy or diabetic peripheral neuropathy
  • Language barrier
  • Neuropsychiatric disorder
  • Severe cardiac or respiratory diseases
  • Pathology or previous surgery or trauma to the lower limb
  • Analgesics intake, history of substance abuse
  • History of spinal surgery or deformity
  • Ultrasound visibility score less than 10
  • Participating in the investigation of another experimental agent

结局指标

主要结局

Onset time of sensory block to cold and pinprick

时间窗: up to 40 min after ropivacaine injection

Onset time of sensory block (cold/pinprick), defined as time interval from completion of local anesthetic injection to the achievement of complete sensory block (defined as no sensation in three major branches including the femoral nerve, the lateral femoral cutaneous nerve and the obturator nerve) .

次要结局

  • Incidence of paresthesia during block(up to 20min after needle insertion)
  • Performance time of block(up to 20 min after needle insertion)
  • Number of needle passes during block(up to 20min after needle insertion)
  • Total ultrasound visibility score (UVS)(30 min before and 5 min after lumbar plexus block)
  • Onset time of motor block(up to 40min after ropivacaine injection)
  • Incidence of accidental vascular puncture(up to 20min after needle insertion)
  • Changes of muscle strength of quadriceps femoris and adductors(up to 40min after ropivacaine injection)
  • Minimal stimulating current of the needle(up to 20min after needle insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Mei

Associate Professor

Huazhong University of Science and Technology

研究点 (1)

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