NCT03044496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

January 31, 2017

Last Update Submit

April 11, 2018

Conditions

Keywords

NIR SpectroscopyNerve BlockadeSurgical Arteriovenous Shunt

Outcome Measures

Primary Outcomes (1)

  • NIRS after block

    Absolute change from baseline value in tissue oxygenation

    5 minutes before block until 30 minutes after block

Secondary Outcomes (1)

  • Difference between both arms

    5 minutes before block until 30 minutes after block

Study Arms (1)

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

Interventions

Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%

Supraclavicular Nerve Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing shunt surgery under supraclavicular plexus block

You may qualify if:

  • all patients undergoing surgery under regional anaesthesia

You may not qualify if:

  • patients refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marienhospital Stuttgart, Dpt. of Anaesthesiology

Stuttgart, Baden-Wurttemberg, 70199, Germany

Location

Related Publications (1)

  • Keuler J, Weiss C, Klemm K, Pochhammer J, Schmidt R, Ilies C. Assessing changes in tissue oxygenation by near-infrared spectroscopy following brachial plexus block for arteriovenous fistula surgery: A prospective observational pilot study. Eur J Anaesthesiol. 2018 Oct;35(10):759-765. doi: 10.1097/EJA.0000000000000871.

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Medical Director Dpt. for Anaesthesiology

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 7, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations