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Continuous Blockade of the Brachial Plexus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769429
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
I. Heermann Anesthesia Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
Arthroses Degenerative Disorder Osteoarthritis Device: Ultrasound-guided CISB Device: nerve stimulator-guided CCPVB

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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)?
Actual Study Start Date : September 19, 2016
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769429


Locations
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United States, Florida
Florida Surgical Center
Gainesville, Florida, United States, 32607
UF Health
Gainesville, Florida, United States, 32610-3003
Sponsors and Collaborators
University of Florida
I. Heermann Anesthesia Foundation
Investigators
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Principal Investigator: Yury Zasimovich University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02769429    
Other Study ID Numbers: IRB201600012
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases