Back to resultsEvaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
Primary Purpose
Pain, Postoperative, Pain, Shoulder Joint
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brachial plexus nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, >18 years old, Non-pregnant, 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
Single-shot Interscalene Nerve Block with ropivacaine 0.5%
Single-shot Supraclavicular Nerve Block with ropivacaine 0.5%
Single-shot Suprascapular Nerve Block with ropivacaine 0.5%
Outcomes
Primary Outcome Measures
Pain
NRS Pain Scale
Secondary Outcome Measures
Lung function
Vital Capacity, Spirometry
Sensory and Motor Function
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynamometer
Diaphragmatic excursion
Ultrasound measuring the diaphragm movement in centimeters (cm)
Full Information
NCT ID
NCT02287142
First Posted
November 5, 2014
Last Updated
January 31, 2017
Sponsor
Benaroya Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02287142
Brief Title
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
Official Title
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Shoulder Joint, Pathologic Processes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interscalene
Arm Type
Active Comparator
Arm Description
Single-shot Interscalene Nerve Block with ropivacaine 0.5%
Arm Title
Supraclavicular
Arm Type
Active Comparator
Arm Description
Single-shot Supraclavicular Nerve Block with ropivacaine 0.5%
Arm Title
Suprascapular
Arm Type
Active Comparator
Arm Description
Single-shot Suprascapular Nerve Block with ropivacaine 0.5%
Intervention Type
Procedure
Intervention Name(s)
Brachial plexus nerve block
Intervention Description
All arms of the study comparing the three different blocks are receiving the same single injection bolus of ropivacaine 0.5% prior to surgery. We will then record and compare pain scores in PACU and opioid requirement.
Primary Outcome Measure Information:
Title
Pain
Description
NRS Pain Scale
Time Frame
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary Outcome Measure Information:
Title
Lung function
Description
Vital Capacity, Spirometry
Time Frame
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Title
Sensory and Motor Function
Description
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynamometer
Time Frame
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Title
Diaphragmatic excursion
Description
Ultrasound measuring the diaphragm movement in centimeters (cm)
Time Frame
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, >18 years old, Non-pregnant, 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
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
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