Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02993939 |
Date of registration:
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12/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block
ISBvsICB-SSB |
Scientific title:
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A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block |
Date of first enrolment:
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December 2016 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02993939 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Chile
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age between 18 and 75 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 30
Exclusion Criteria:
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically
necessary, by blood work up i.e. platelets = 100, International Normalized Ratio = 1.4
or prothrombin time = 50)
- obstructive or restrictive pulmonary disease (assessed by history and physical
examination)
- renal failure (assessed by history and physical examination and, if deemed clinically
necessary, by blood work up i.e. creatinine = 100)
- hepatic failure (assessed by history and physical examination and, if deemed
clinically necessary, by blood work up i.e. transaminases = 100)
- allergy to local anesthetics (LAs)
- pregnancy
- prior surgery in the neck, infraclavicular region or suprascapular fossa
- chronic pain syndromes requiring opioid intake at home
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Shoulder Injury
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Intervention(s)
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Procedure: Infraclavicular-suprascapular block
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Procedure: Interscalene block
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Primary Outcome(s)
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Static Pain using numeric scale 0-10
[Time Frame: 30 minutes after arrival to PACU]
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Secondary Outcome(s)
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Static Pain using numeric scale 0-10
[Time Frame: 24 hrs]
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Static Pain using numeric scale 0-10
[Time Frame: 12 hrs after arrival to PACU]
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Diaphragm paralysis incidence
[Time Frame: 30 minutes after block]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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