Continuous Blockade of the Brachial Plexus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)?

Conditions
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Arthroses, Degenerative Disorder, Osteoarthritis

Intervention / Treatment
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* Device: Ultrasound-guided CISB
* Device: nerve stimulator-guided CCPVB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ultrasound-guided CISB<br>Group 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus | Device: Ultrasound-guided CISB<br>* This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus<br>|
| nerve stimulator-guided CCPVB<br>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<br>* 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<br>|

What is the study measuring?
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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) |