- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02287142
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
January 31, 2017 updated by: David Auyong, Benaroya Research Institute
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Virginia Mason Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interscalene
Single-shot Interscalene Nerve Block with ropivacaine 0.5%
|
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.
|
Active Comparator: Supraclavicular
Single-shot Supraclavicular Nerve Block with ropivacaine 0.5%
|
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.
|
Active Comparator: Suprascapular
Single-shot Suprascapular Nerve Block with ropivacaine 0.5%
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
NRS Pain Scale
|
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Vital Capacity, Spirometry
|
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Sensory and Motor Function
Time Frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynamometer
|
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Diaphragmatic excursion
Time Frame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Ultrasound measuring the diaphragm movement in centimeters (cm)
|
Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Auyong, MD, Virginia Mason Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 6, 2014
First Posted (Estimate)
November 10, 2014
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 14013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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