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NCT Number: NCT06931756

Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block

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.

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Key information

Conditions

Electrical Stimulation of Nerves Produces Muscle Reflexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neural Stimulator

Device

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 response is elicited, the current intensity is appropriately increased to achieve a motor response of the extensor tendon of the radial nerve, and the flexor tendon motor responses of the ulnar nerve, median nerve, and musculocutaneous nerve.

Primary outcomes

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

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.

Secondary outcomes

The onset time of forearm sensory block in two groups of patients

Time frame: one year

Testing the time for cold sensation disappearance using alcohol swabs
Onset time of forearm motor block in two groups of patients

Time frame: one year

Time when forearm muscle strength drops to grade 0.
The recovery time of forearm sensation in two groups of patients

Time frame: one year

Forearm tactile recovery time
Recovery time for forearm movement in two groups of patients

Time frame: one year

Time for forearm muscle strength to recover to pre-surgery status

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 17, 2025
Registry last updated: Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.