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This study has been withdrawn prior to enrollment.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

April 18, 2008
April 9, 2010
April 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00663715 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Ultrasound Description of the Sciatic Nerve
Anatomical Description of the Sciatic Nerve Via a Lateral Mid-Thigh Approach Using Ultrasound

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Pediatric patients

  • Sciatic Nerve AH
  • Peripheral Nerves US
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
1
Pediatric Patients of ages 11-17
Intervention: Other: Observation of the Sciatic Nerve
Karmakar MK, Kwok WH, Ho AM, Tsang K, Chui PT, Gin T. Ultrasound-guided sciatic nerve block: description of a new approach at the subgluteal space. Br J Anaesth. 2007 Mar;98(3):390-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
February 2010
February 2010   (final data collection date for primary outcome measure)

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

Both
11 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00663715
2008-02-5808
No
Arjunan Ganesh, MBBS, The Children's Hospital Of Philadelphia
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Principal Investigator: Arjunan Ganesh, MBBS Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP