Continuous Blockade of the Brachial Plexus

July 23, 2019 updated by: University of Florida

Is There a Difference Between Posterior Approach Ultrasound-guided Continuous Interscalene Block (Upper Trunk Block) and Stimulator Guided Continuous Cervical Paravertebral Block (C6 Root Block)?

This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.

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

This is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the CCPVB, which focusses on the six cervical nerve root (C6 root), and CISB, which focuses on the upper trunk of the brachial plexus. Data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (RNL) function, ipsilateral Horner's syndrome, block time and medication doses used for block placement, will be collected. All observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.

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.
53

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • UF Health
      • Gainesville, Florida, United States, 32607
        • Florida Surgical Center

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital

Description

Inclusion Criteria:

  • The general inclusion will be those adult patients who:

    • are between the ages of 18 and 80 years
    • have an ASA Health Classification of I, II, or III
    • are scheduled for shoulder arthroplasty or rotator cuff repair surgery
    • Patients with a BMI of =to/< 40 Exclusion

The Exclusion criteria will include:

  • Patient refusal to participate in the study or sign informed consent
  • Patients with contraindications to any of the two blocks or allergy to any of the drugs used
  • Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair
  • Patients with a BMI >40

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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 CISB
Group 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
Device: Ultrasound-guided CISB
This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
nerve stimulator-guided CCPVB
Group 2 will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root
Device: nerve stimulator-guided CCPVB
This group will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root

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
Changes between the two groups assessed by sensory testing
Time Frame: Change from baseline up to 7 days (end of catheter placement)
Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation.
Change from baseline up to 7 days (end of catheter placement)

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
Changes between the two groups assessed by motor strength
Time Frame: Change from baseline up to 7 days (end of catheter placement)
Motor strength will be assessed on a scale of 0 to 5 Medical Research Council (MRC) scale
Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by shoulder pain
Time Frame: Change from baseline up to 7 days (end of catheter placement)
Shoulder pain will be assessed by the Defense and Veterans Pain Rating Scale (DVPRS) where pain will be rated as no pain, mild, moderate, or severe pain, and on a scale of 0 to 10 where 0 represents no pain, 1 to 3 represents mild pain, 4 to 6 represents moderate pain, 7 to 9 represents severe pain, and 10 represents the worst pain imaginable where nothing else but the pain matters
Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by Phrenic nerve function
Time Frame: Change from baseline up to 7 days (end of catheter placement)
Phrenic nerve function will be evaluated by measuring the movements of the diaphragm by ultrasonography or the inability to visualize using ultrasound (US)
Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function
Time Frame: Change from baseline up to 7 days (end of catheter placement)
RLN function will be assessed by hoarseness or swallowing difficulty
Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by development of ipsilateral Horner's syndrome
Time Frame: Change from baseline up to 7 days (end of catheter placement)
Development of ipsilateral Horner's syndrome
Change from baseline up to 7 days (end of catheter placement)

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.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
I. Heermann Anesthesia Foundation

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: Yury Zasimovich, University of Florida

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.
September 19, 2016

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.
June 6, 2018

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.
September 26, 2018

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 9, 2016

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.
May 10, 2016

First Posted (Estimate)

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.
May 11, 2016

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.
July 25, 2019

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.
July 23, 2019

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.
July 1, 2019

More Information

Terms related to this study

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.
  • IRB201600012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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