Documents
All documents related to The BLOCK Trial can be found below.
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BLOCK Trial Synopsis
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BLOCK Trial Protocol
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BLOCK Trial Protocol article
Standard Operating Procedures (SOP)
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Screening
Screening of trial participants
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Inclusion and Randomisation
Inclusion and Randomisation of trial participants
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Trial Medicine
Overall preparation of trial medicine
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LIC / AXIL Procedure
Description of the ultrasound-guided brachial plexus nerve block procedure
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Plexus Nerve Block Test
Evaluation of block success.
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Unblinding Procedure
Description of unblinding procedure
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System Failure
Procedure for datacollection during system failure.
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Delegation Log
Procedures for registration of doctors taking care of patient inclusion.
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Monitorering and Registration of AEs and SAEs
Description of monitoration and registration of adverse events (<24 h) and serious adverse events (<90 d)
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Documentation in the patient's medical journal
Procedures for documentation and procedure registration in the trial participant’s medical journal.