NIRS Measurement After SCP Block

April 11, 2018 updated by: Dr. Christoph Ilies, Marienhospital Stuttgart

Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

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

  • Germany
    • Baden Württemberg
      • Stuttgart, Baden Württemberg, Germany, 70199
        • Marienhospital Stuttgart, Dpt. of Anaesthesiology

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing shunt surgery under supraclavicular plexus block

Description

Inclusion Criteria:

  • all patients undergoing surgery under regional anaesthesia

Exclusion Criteria:

  • patients refusal

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIRS after block
Time Frame: 5 minutes before block until 30 minutes after block
Absolute change from baseline value in tissue oxygenation
5 minutes before block until 30 minutes after block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes before block until 30 minutes after block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marienhospital Stuttgart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRS after SCP block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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