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Changes in Tissue Oxygenation Following Regional Anesthesia

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.
ClinicalTrials.gov Identifier: NCT01418690
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:

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.

Condition or disease
Anesthesia, Local

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Tissue Oxygenation Following Regional Anesthesia
Study Start Date : September 2011
Primary Completion Date : April 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Non-invasive near infra-red device (NIRS)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring regional anesthetics.

Inclusion Criteria:

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

Exclusion Criteria:

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): NCT01418690

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01418690     History of Changes
Other Study ID Numbers: IRB11-00509
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016