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NIRS Measurement After SCP Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03044496
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Dr. Christoph Ilies, Marienhospital Stuttgart

Brief Summary:

Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .

Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .

The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.

Condition or disease Intervention/treatment
Arterio-venous Fistula Drug: Supraclavicular nerve block

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
Supraclavicular Nerve Block
Patients undergoing vascular surgery for creation or revision of an arterio-venous fistula. Intervention: supraclavicular plexus block for anaesthesia. NIRS measurement before and after brachial plexus block.
Drug: Supraclavicular nerve block
Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%

Primary Outcome Measures :
  1. NIRS after block [ Time Frame: 5 minutes before block until 30 minutes after block ]
    Absolute change from baseline value in tissue oxygenation

Secondary Outcome Measures :
  1. Difference between both arms [ Time Frame: 5 minutes before block until 30 minutes after block ]
    Absolute difference in tissue oxygenation between blocked arm and contralateral arm

Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
All patients undergoing shunt surgery under supraclavicular plexus block

Inclusion Criteria:

  • all patients undergoing surgery under regional anaesthesia

Exclusion Criteria:

  • patients refusal

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 identifier (NCT number): NCT03044496

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Marienhospital Stuttgart, Dpt. of Anaesthesiology
Stuttgart, Baden Württemberg, Germany, 70199
Sponsors and Collaborators
Marienhospital Stuttgart

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Christoph Ilies, Principal Investigator, Assistant Medical Director Dpt. for Anaesthesiology, Marienhospital Stuttgart Identifier: NCT03044496    
Other Study ID Numbers: NIRS after SCP block
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
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 Dr. Christoph Ilies, Marienhospital Stuttgart:
NIR Spectroscopy
Nerve Blockade
Surgical Arteriovenous Shunt
Additional relevant MeSH terms:
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Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities