Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery
Primary Purpose
Post-Operative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Pain
Eligibility Criteria
Inclusion Criteria:
- Unilateral total shoulder arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant (or lactating)
- Consent to participate in the study
Exclusion Criteria:
- Refusal to participate
- < 18 years old
- Chronic opioid use
- Localized infection
- Pregnancy or lactating
- Pre-existing coagulopathy
- Allergy to ultrasound gel or local anesthetics
- Diaphragmatic dysfunction
Sites / Locations
- Virginia Mason Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Interscalene
Supraclavicular
Suprascapular
Arm Description
Continuous Interscalene Nerve Block
Continuous Supraclavicular Nerve Block
Continuous Suprascapular Nerve Block
Outcomes
Primary Outcome Measures
Lung function
Vital Capacity, Spirometry
Secondary Outcome Measures
Pain
NRS Pain Scale
Opioid Consumption
Total opioid consumption x 24 hours
Sensory and Motor Function
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynometer
Full Information
NCT ID
NCT02117778
First Posted
January 24, 2014
Last Updated
February 2, 2017
Sponsor
Benaroya Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02117778
Brief Title
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery
Official Title
A Comparative Pulmonary Function Study of Continuous Supraclavicular, Suprascapular, and Interscalene Nerve Catheters After Total Shoulder Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benaroya Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interscalene
Arm Type
Active Comparator
Arm Description
Continuous Interscalene Nerve Block
Arm Title
Supraclavicular
Arm Type
Active Comparator
Arm Description
Continuous Supraclavicular Nerve Block
Arm Title
Suprascapular
Arm Type
Active Comparator
Arm Description
Continuous Suprascapular Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Continuous Nerve Block
Primary Outcome Measure Information:
Title
Lung function
Description
Vital Capacity, Spirometry
Time Frame
Post-Operative Day 1
Secondary Outcome Measure Information:
Title
Pain
Description
NRS Pain Scale
Time Frame
Post Operative Day 1
Title
Opioid Consumption
Description
Total opioid consumption x 24 hours
Time Frame
Post Operative Day 1
Title
Sensory and Motor Function
Description
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynometer
Time Frame
Post Operative Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral total shoulder arthroplasty
ASA physical status I-III
>18 years old
Non-pregnant (or lactating)
Consent to participate in the study
Exclusion Criteria:
Refusal to participate
< 18 years old
Chronic opioid use
Localized infection
Pregnancy or lactating
Pre-existing coagulopathy
Allergy to ultrasound gel or local anesthetics
Diaphragmatic dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Auyong, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery
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