NCT02769429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 19, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

May 9, 2016

Last Update Submit

July 23, 2019

Conditions

ArthrosesDegenerative DisorderOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes between the two groups assessed by motor strength

    Change from baseline up to 7 days (end of catheter placement)

  • Changes between the two groups assessed by shoulder pain

    Change from baseline up to 7 days (end of catheter placement)

  • Changes between the two groups assessed by Phrenic nerve function

    Change from baseline up to 7 days (end of catheter placement)

  • Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function

    Change from baseline up to 7 days (end of catheter placement)

  • Changes between the two groups assessed by development of ipsilateral Horner's syndrome

    Change from baseline up to 7 days (end of catheter placement)

Study Arms (2)

ultrasound-guided CISB

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

Device: Ultrasound-guided CISB

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

Device: nerve stimulator-guided CCPVB

Interventions

Ultrasound-guided CISBDEVICE

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

ultrasound-guided CISB
nerve stimulator-guided CCPVBDEVICE

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

nerve stimulator-guided CCPVB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are are scheduled for shoulder arthroplasty or rotator cuff repair surgery at an area hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida Surgical Center

Gainesville, Florida, 32607, United States

Location

UF Health

Gainesville, Florida, 32610-3003, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yury Zasimovich

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

September 19, 2016

Primary Completion

June 6, 2018

Study Completion

September 26, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)