Changes in Tissue Oxygenation Following Regional Anesthesia
1 other identifier
observational
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 29, 2016
November 1, 2016
7 months
August 16, 2011
November 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Tissue oxygenation
NIRS values from two sites before and after the regional anesthetic is placed.
1 Day (Day of Surgery)
Study Arms (1)
Non-invasive near infra-red device (NIRS)
Eligibility Criteria
Patients requiring regional anesthetics.
You may qualify if:
- Patients undergoing a surgical procedure who have consented to a regional block.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 17, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2012
Study Completion
June 1, 2012
Last Updated
November 29, 2016
Record last verified: 2016-11