Continuous Blockade of the Brachial Plexus

NCT ID: NCT02769429

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-19
• Study Completion Date: 2018-09-26

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.

Conditions

Arthroses; Degenerative Disorder; Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ultrasound-guided CISB

Group 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus

Ultrasound-guided CISB

Intervention Type: DEVICE

This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus

nerve stimulator-guided CCPVB

Group 2 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

nerve stimulator-guided CCPVB

Intervention Type: DEVICE

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

Interventions

Ultrasound-guided CISB

This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I. Heermann Anesthesia Foundation

UNKNOWN

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yury Zasimovich

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Florida Surgical Center

Gainesville, Florida, United States

UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201600012

Identifier Type: -

Identifier Source: org_study_id