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临床试验/NCT06931756
NCT06931756尚未招募不适用

Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block: One Prospective Parallel Cohort Study

Nanjing First Hospital, Nanjing Medical University0 个研究点目标入组 60 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
The difference in the minimum excitatory threshold current for motor electrical stimulation of the radial, ulnar, median, and musculocutaneous nerves between patients with uremia and those without uremia.

研究概览

简要总结

As a late stage of renal failure, uremia not only leads to severe impairment of renal function in patients, but also often leads to a variety of complications, among which multiple peripheral neuropathy is particularly common. This lesion is mainly caused by the combination of multiple mechanisms, such as the accumulation of uremic toxins, electrolyte disorder, nutrient deficiency and factors related to hemodialysis. Therefore, it is important clinical significance to deeply explore the effects of uremia on electrophysiological properties and nerve block of brachial plexus.

At present, there are relatively few studies on the effects of uremia on the brachial plexus, especially the prospective parallel cohort studies on its electrophysiological properties and nerve block. As a new anesthetic technique, ultrasound-guided axillary brachial plexus block has the advantages of precise positioning, scientific administration, reducing complications and improved safety, but the application effect and safety in uremic patients still need to be further verified.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Uremia group [group U]
  • Patients aged 18 years and older
  • ASA classification I-IV
  • BMI 18.5-29.9
  • Patients with uremia planning to undergo forearm or hand surgery
  • Diagnostic criteria: Patients must meet the internationally recognized diagnostic criteria for uremia and require hemodialysis
  • Informed consent: Patients or their legal representatives must sign an informed consent form, agreeing to participate in this study and undergo related examinations and treatments
  • Non-uremia group [Group N]
  • Patients aged 18 years and older
  • ASA classification I-IV
  • BMI 18.5-29.9
  • Patients planning to undergo forearm or hand surgery
  • In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy
  • The patient or their legal representative must sign an informed consent form, agreeing to participate in this study and receive the relevant examinations and treatments

排除标准

  • Individuals allergic to study medications (such as ropivacaine)
  • Those with contraindications to local anesthesia or nerve blockades, such as coagulation disorders, infections, etc.
  • Those with severe cardiovascular or respiratory diseases
  • Those unable to comply with study requirements, such as cognitive impairment, mental disorders, etc.
  • Pregnant women

结局指标

主要结局

The difference in the minimum excitatory threshold current for motor electrical stimulation of the radial, ulnar, median, and musculocutaneous nerves between patients with uremia and those without uremia.

时间窗: one year

Under ultrasound guidance, using a high-frequency linear array transducer and a dedicated nerve stimulation needle, the nerves are localized in-plane technique under direct visualization. Adjust the nerve stimulator with a stimulation duration of 0.1 ms, a stimulation frequency of 1Hz, and a stimulation current of 1.0mA. Under ultrasound guidance, the needle tip is used to touch the radial nerve, ulnar nerve, median nerve, and musculocutaneous nerve respectively, until a clear motor response is observed in the corresponding muscles. Thereafter, the minimum stimulation threshold current is verified by reducing the current until the distal motor response disappears. If no motor response is elicited, the current intensity is appropriately increased to achieve motor responses of the extensor tendon of the radial nerve, and the flexor tendons of the ulnar nerve, median nerve, and musculocutaneous nerve.

次要结局

  • The onset time of forearm sensory block in two groups of patients(one year)
  • Onset time of forearm motor block in two groups of patients(one year)
  • The recovery time of forearm sensation in two groups of patients(one year)
  • Recovery time for forearm movement in two groups of patients(one year)

研究者

申办方类型
Other
责任方
Sponsor

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