Changes in Tissue Oxygenation Following Regional Anesthesia

November 28, 2016 updated by: Joseph D. Tobias, Nationwide Children's Hospital

Adequate tissue oxygenation is required for effective white blood cell function and bactericidal activity. Decreased tissue oxygenation is a risk factor for perioperative wound infections. Regional anesthetic techniques result in a functional sympathetic block and may increase tissue oxygenation. The purpose of this study is to evaluate changes in tissue oxygenation using a non-invasive Near-infrared spectroscopy (NIRS) device. The current study will evaluate changes in tissue oxygenation following regional anesthetic techniques (peripheral nerve blockade and neuraxial techniques such as caudal block) in pediatric patients).

Regional anesthesia will induce a sympathetic blockade and improve tissue oxygenation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

29

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring regional anesthetics.

Description

Inclusion Criteria:

  • Patients undergoing a surgical procedure who have consented to a regional block.

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Non-invasive near infra-red device (NIRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue oxygenation
Time Frame: 1 Day (Day of Surgery)
NIRS values from two sites before and after the regional anesthetic is placed.
1 Day (Day of Surgery)

Collaborators and Investigators

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

Sponsor

Nationwide Children's Hospital

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

September 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IRB11-00509

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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