Arthroses, Degenerative Disorder, Osteoarthritis
Conditions
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.
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.
Interventions
DEVICEUltrasound-guided CISB
This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
DEVICEnerve 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
Sponsors
I. Heermann Anesthesia Foundation
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes between the two groups assessed by sensory testing | Change from baseline up to 7 days (end of catheter placement) | Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes between the two groups assessed by motor strength | 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 |
| Changes between the two groups assessed by shoulder pain | 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 |
| Changes between the two groups assessed by Phrenic nerve function | 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) |
| Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function | Change from baseline up to 7 days (end of catheter placement) | RLN function will be assessed by hoarseness or swallowing difficulty |
| Changes between the two groups assessed by development of ipsilateral Horner's syndrome | Change from baseline up to 7 days (end of catheter placement) | Development of ipsilateral Horner's syndrome |
Countries
United States
Outcome results
None listed