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Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks (Visibility)

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ClinicalTrials.gov Identifier: NCT03231696
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jurgen Birnbaum, Charite University, Berlin, Germany

Study Description
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Brief Summary:
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

Condition or disease
Anesthesia, Local Anesthesia

Detailed Description:

We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.

Study Design
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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Visibility - A Novel Classification Score of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016
Groups and Cohorts
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Group/Cohort
Patients receiving Regional Anesthesia
All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.


Outcome Measures
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Primary Outcome Measures :
  1. Visibility [ Time Frame: During regional block (an average of 1 hour) ]
    The ultrasound visibility of the nerve scored by a 5-step scale.


Secondary Outcome Measures :
  1. Additional analgesia [ Time Frame: During surgery (an average of 4 hours) ]
    The need and amount of additional analgetic drugs while the intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.
Criteria

Inclusion Criteria (study sample N=1200):

  • peripheral nerve block by ultrasound guidance
  • age ≥ 18 years

Exclusion Criteria:

  • contraindications for regional anesthesia

Inclusion Criteria (study sample as of amendment n=46):

  • peripheral nerve block by ultrasound guidance
  • age ≥ 18 years

Exclusion Criteria:

  • contraindications for regional anesthesia (study sample n=46)
  • using not the standard ultrasound machine
  • performing not a standard regional anesthesia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231696


Locations
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Germany
Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Jürgen Birnbaum, MD Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
More Information
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Responsible Party: Jurgen Birnbaum, Senior physician of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03231696    
Other Study ID Numbers: Visibility
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jurgen Birnbaum, Charite University, Berlin, Germany:
nerve block
peripheral nerve stimulation