Changes in Tissue Oxygenation Following Regional Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01418690
First received: August 16, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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
Cases Requiring a Regional Anesthetic.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Changes in Tissue Oxygenation Following Regional Anesthesia

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Tissue oxygenation [ Time Frame: 1 Day (Day of Surgery) ] [ Designated as safety issue: No ]
    NIRS values from two sites before and after the regional anesthetic is placed.


Enrollment: 29
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-invasive near infra-red device (NIRS)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring regional anesthetics.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418690

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

No publications provided

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
Study First Received: August 16, 2011
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014