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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418690
Other study ID # IRB11-00509
Secondary ID
Status Completed
Phase N/A
First received August 16, 2011
Last updated November 28, 2016
Start date September 2011
Est. completion date June 2012

Study information

Verified date November 2016
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date June 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tissue oxygenation NIRS values from two sites before and after the regional anesthetic is placed. 1 Day (Day of Surgery) No
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