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Completed

NCT Number: NCT02769429

Continuous Blockade of the Brachial Plexus

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.

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Key information

Conditions

Arthroses Arthritis Degenerative Disorder Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Surgical Center, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasound-guided CISB

Device

This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus

nerve stimulator-guided CCPVB

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • I. Heermann Anesthesia Foundation

Registry information

Official study 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)?

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 11, 2016
Registry last updated
Jul 25, 2019

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.

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