Continuous Blockade of the Brachial Plexus

Completed

• Conditions: Arthroses; Degenerative Disorder; Osteoarthritis
• Interventions: Device: Ultrasound-guided CISB; Device: nerve stimulator-guided CCPVB

• Registration Number: NCT02769429
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2016-09-19
• Primary Completion: 2018-06-06
• Study Completion: 2018-09-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound-guided CISB	Ultrasound-guided CISB	Group 1 will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
nerve stimulator-guided CCPVB	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 development of ipsilateral Horner's syndrome	Change from baseline up to 7 days (end of catheter placement)	Development of ipsilateral Horner's syndrome

Trial Locations

Locations (2)

Florida Surgical Center; 🇺🇸 Gainesville, Florida, United States

UF Health; 🇺🇸 Gainesville, Florida, United States