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Ultrasound Description of the Sciatic Nerve

This study has been withdrawn prior to enrollment.
(No subjects were enrolled. Sciatic blocks infrequently used for pain control.)
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00663715
First received: April 18, 2008
Last updated: April 9, 2010
Last verified: April 2010
  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

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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (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.
Other Names:
  • Sciatic Nerve location
  • Peripheral Nerve Blocks

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
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: NCT00663715

Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Arjunan Ganesh, MBBS Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Arjunan Ganesh, MBBS, The Children's Hospital Of Philadelphia
ClinicalTrials.gov Identifier: NCT00663715     History of Changes
Other Study ID Numbers: 2008-02-5808
Study First Received: April 18, 2008
Last Updated: April 9, 2010
Health Authority: United States: Institutional Review Board

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 November 23, 2014