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.
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
53
This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
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
Florida Surgical Center
Gainesville, Florida, United States
UF Health
Gainesville, Florida, United States
Changes between the two groups assessed by sensory testing
Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation.
Time frame: Change from baseline up to 7 days (end of catheter placement)
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Change from baseline up to 7 days (end of catheter placement)
Changes between the two groups assessed by development of ipsilateral Horner's syndrome
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Development of ipsilateral Horner's syndrome
Time frame: Change from baseline up to 7 days (end of catheter placement)