USG Block of Cutaneous Nerves of the Arm

April 8, 2024 updated by: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Ultrasound-Guided Plane Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves：A Retrospective Observational Study

For superficial surgery of anteromedial and posteromedial surfaces of the upper arm, the medial brachial cutaneous nerve (MBCN) and the intercostobrachial nerve (ICBN) must be selectively blocked, in addition to an axillary brachial plexus block. We compared efficacy of ultrasound-guided (USG) versus conventional block of the MBCN and the ICBN.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

The primary objective of our study was to compare the effectiveness of conventional and USG blocks of the MBCN and the ICBN in the axillary fossa. Our hypothesis was that the proportion of patients with complete anesthesia in the entire posteromedial and anteromedial surface of the arm would be greater if a USG technique were used, compared with a conventional technique. The secondary objectives were onset time of complete anesthesia, volume of local anesthetic used for the procedure, tourniquet tolerance during surgery, and ultrasound visibility of MBCN and ICBN.

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.
Observational

Enrollment (Actual)

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.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hebei
      • Cangzhou, Hebei, China, 061001
        • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

200

Description

Inclusion Criteria:

  • Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
  • Urgent or planned surgery
  • Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block

Exclusion Criteria:

  • Refused to sign informed consent
  • Pregnant women
  • Allergic to the local anesthetic

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Ultrasound-Guided
Ultrasound-Guided Plane Block
Procedure: Ultrasound-Guided Plane Block
Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
Conventional
Conventional Block
Procedure: Conventional Block
Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves

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
Number of participants with complete anesthesia
Time Frame: At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block
Number of participants with complete anesthesia of the arm in region innervated by the MBCN and the ICBN
At time 20 minutes after the medial brachial cutaneous nerve and the intercostobrachial nerve block

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
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia
Time Frame: At times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia at times 5, 10, 15, 20 minutes (except primary outcome) in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
At times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Volume of local anesthetic
Time Frame: After nerve block immediately
The volume (in milliliters) of 1% lidocaine used for the medial brachial cutaneous nerve and the intercostobrachial nerve block
After nerve block immediately
Tourniquet tolerance
Time Frame: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of patients with comfortable feeling, with unpleasant sensations and with pains during surgery, in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Good ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Bad ultrasound view of theses nerves before and after the injection of the local anesthetic
Time Frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic
5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block

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.
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruizha Lv, M.D, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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 (Actual)

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 1, 2019

Primary Completion (Actual)

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.
May 1, 2021

Study Completion (Actual)

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.
July 1, 2021

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).
May 8, 2018

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 25, 2019

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 26, 2019

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 9, 2024

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 8, 2024

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, 2019

More Information

Terms related to this study

Keywords

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.
  • 2019CZTCWM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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