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Not yet recruiting NCT06931756

Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block

No phase Interventional Electrical Stimulation of Nerves Produces Muscle Reflexes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neural Stimulator.
Who it may be relevant to
Registry conditions: Electrical Stimulation of Nerves Produces Muscle Reflexes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Neural Stimulator
    Adjust the neural 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 r

Primary outcome measures

  • 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. [Time frame: one year]
Secondary outcome measures (4)
  • The onset time of forearm sensory block in two groups of patients [Time frame: one year]
  • Onset time of forearm motor block in two groups of patients [Time frame: one year]
  • The recovery time of forearm sensation in two groups of patients [Time frame: one year]
  • Recovery time for forearm movement in two groups of patients [Time frame: one year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06931756 · KY20250123-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗