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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00663715
Other study ID # 2008-02-5808
Secondary ID
Status Withdrawn
Phase N/A
First received April 18, 2008
Last updated March 11, 2015
Start date April 2009
Est. completion date February 2010

Study information

Verified date April 2010
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 17 Years
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Observation of the Sciatic Nerve
Ultrasound will be used to determine the location of the Sciatic Nerve using a lateral mid-thigh approach.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Children's Anesthesiology Associates, Ltd.

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 minutes No
Secondary A secondary objective is to describe correlations between any of the measured variables and the patient's mid-thigh circumference or weight. 10 minutes No