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Ultrasound Description of the Sciatic Nerve

This study is currently recruiting participants.
Verified by Children's Hospital of Philadelphia, April 2008

Sponsors and Collaborators: Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00663715
  Purpose

Sciatic nerve blocks are frequently used for anesthesia or analgesia for surgery of the lower legs. Currently, if ultrasound is used to find the sciatic nerve, the leg must be raised to locate the nerve with the ultrasound probe on the back of the thigh. In pediatric surgery, the patients are anesthetized (asleep) before the block is given. It is difficult for one person to administer the sciatic nerve block using this method. We would like to identify the sciatic nerve using ultrasound on the side of the thigh and its location to the adjacent structures.


Condition Intervention
Sciatic Nerve AH
Peripheral Nerves US
Other: Observation of the Sciatic Nerve

MedlinePlus related topics:   Anatomy    Anesthesia    Ultrasound   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Anatomical Description of the Sciatic Nerve Via a Lateral Mid-Thigh Approach Using Ultrasound

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The primary objective is to describe the appearance of the sciatic nerve and its location in relation to adjacent anatomic structures using ultrasound from the lateral mid-thigh position. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary objective is to describe correlations between any of the measured variables and the patient's mid-thigh circumference or weight. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   40
Study Start Date:   April 2008
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Pediatric Patients of ages 11-17
Other: Observation of the Sciatic Nerve
Ultrasound will be used to determine the location of the Sciatic Nerve using a lateral mid-thigh approach.

Detailed Description:

The sciatic nerve block is frequently used for anesthesia or analgesia for surgery of the lower extremities. Ultrasound-guided sciatic nerve blocks performed at the lateral mid-femoral level have been successfully described with subjects in the supine position and the lower limb elevated in order to accommodate the ultrasound probe against the posterior aspect of the thigh. In the pediatric setting in which nerve blocks are commonly performed with the patient anesthetized rather than awake, we find this technique to be unwieldy as a single-operator technique. Using a more ergonomic approach that has not been previously described, we plan to identify and describe the sciatic nerve with the ultrasound positioned against the lateral aspect of the thigh. We hope to describe the appearance of the sciatic nerve and its location in relation to adjacent anatomic structures using this modified approach.

This a prospective cross-sectional study of 40 pediatric subjects 11-17 years of age. Three ultrasound images of the sciatic nerve will be obtained via the lateral mid-thigh approach in 40 pediatric patients scheduled to undergo sciatic nerve block - the first image prior to placement of the block, the second after the nerve is located by the stimulating needle and the third after the injection of local anesthetic.

  Eligibility
Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Pediatric patients


Criteria

Inclusion Criteria:

  1. Males or females 11 to 17 years old.
  2. Patients undergoing lower extremity surgery who are scheduled to have a sciatic nerve block as part of the anesthetic.
  3. Parental/guardian permission (verbal consent) and child assent. Note: if you record ANY PHI, you will need to obtain written consent since HIPAA requires written authorization for use of PHI.

Exclusion Criteria:

None

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663715

Contacts
Contact: George Liu, MD     1-267-426-5894     liug@email.chop.edu    
Contact: Arjunan Ganesh, MD     1-215-590-1623     ganesha@email.chop.edu    

Locations
United States, Pennsylvania
The Children's Hospital Of Philadelphia     Recruiting
      Philadelphia, Pennsylvania, United States, 19104
      Contact: Arjunan Ganesh, MBBS     215-590-1623     ganesha@email.chop.edu    
      Contact: George Liu, MD     267-426-5891     liug@email.chop.edu    
      Principal Investigator: Arjunan Ganesh, MD            

Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.

Investigators
Principal Investigator:     Arjunan Ganesh, MD     Children's Hospital of Philadelphia    
  More Information

Publications:

Responsible Party:   The Children's Hospital Of Philadelphia ( Arjunan Ganesh, MD )
Study ID Numbers:   2008-02-5808
First Received:   April 18, 2008
Last Updated:   April 18, 2008
ClinicalTrials.gov Identifier:   NCT00663715
Health Authority:   United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Sciatic Nerve  
Peripheral Nerve Block  
Lower extremity surgery  
Local Anesthesia  
Ultrasound guided nerve blocks  

ClinicalTrials.gov processed this record on September 05, 2008




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