Continuous Blockade of the Brachial Plexus

Osteoarthritis Clinical Trial

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)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769429
• Other study ID #: IRB201600012
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Arthroses
• Degenerative Disorder
• Joint Diseases
• Osteoarthritis

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)