Clinical trial NCT02769429: Continuous Blockade of the Brachial Plexus
Official 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)?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroses
Degenerative Disorder
Osteoarthritis
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: I. Heermann Anesthesia Foundation
First posted: 2016-05-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes between the two groups assessed by sensory testing
timeFrame: Change from baseline up to 7 days (end of catheter placement)
Secondary outcomes:
measure: Changes between the two groups assessed by motor strength
timeFrame: Change from baseline up to 7 days (end of catheter placement)
measure: Changes between the two groups assessed by shoulder pain
timeFrame: Change from baseline up to 7 days (end of catheter placement)
measure: Changes between the two groups assessed by Phrenic nerve function
timeFrame: Change from baseline up to 7 days (end of catheter placement)
measure: Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function
timeFrame: Change from baseline up to 7 days (end of catheter placement)
measure: Changes between the two groups assessed by development of ipsilateral Horner's syndrome
timeFrame: Change from baseline up to 7 days (end of catheter placement)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Florida Surgical Center
state: Florida
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Yury Zasimovich
role: PRINCIPAL_INVESTIGATOR
References: