Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block

April 9, 2025 updated by: Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Uremia group [group U]

    1. Patients aged 18 years and older
    2. ASA classification I-IV
    3. BMI 18.5-29.9
    4. Patients with uremia planning to undergo forearm or hand surgery
    5. Diagnostic criteria: Patients must meet the internationally recognized diagnostic criteria for uremia and require hemodialysis
    6. 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]

    1. Patients aged 18 years and older
    2. ASA classification I-IV
    3. BMI 18.5-29.9
    4. Patients planning to undergo forearm or hand surgery
    5. In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy
    6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Uremia group (U group)
  1. Patients aged 18 years and above, ASA classification I-IV, BMI 18.5-29.9, planning to undergo forearm or hand surgery.
  2. Diagnostic criteria: Patients who meet the internationally recognized diagnostic criteria for uremia and require hemodialysis.
  3. 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.
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 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.
Experimental: Non-uremia group (Group N)
  1. According to the Propensity Score Matching (PSM) design for the control group, select patients aged 18 years or older, ASA classification I to IV, matched with patients in the U group in terms of age, gender, and BMI within the corresponding group, who are planned to undergo forearm or hand surgery. In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy.
  2. Informed consent: Similar to the uremic patient group, an informed consent form must be signed.
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
one year
Onset time of forearm motor block in two groups of patients
Time Frame: one year
Time when forearm muscle strength drops to grade 0.
one year
The recovery time of forearm sensation in two groups of patients
Time Frame: one year
Forearm tactile recovery time
one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20250123-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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