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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02769429
Other study ID # IRB201600012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 19, 2016
Est. completion date September 26, 2018

Study information

Verified date July 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date September 26, 2018
Est. primary completion date June 6, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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
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

Locations

Country Name City State
United States Florida Surgical Center Gainesville Florida
United States UF Health Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida I. Heermann Anesthesia Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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