Continuous Blockade of the Brachial Plexus

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: Completed
• Conditions: Osteoarthritis; Degenerative Disorder; Arthroses
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes between the two groups assessed by sensory testing	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

Outcome Measure	Measure Description	Time Frame
Changes between the two groups assessed by motor strength	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	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	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	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	Development of ipsilateral Horner's syndrome	Change from baseline up to 7 days (end of catheter placement)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: I. Heermann Anesthesia Foundation
• Investigators: Principal Investigator: Yury Zasimovich, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID 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